Legit.Health Plus STED
Table of contents
- Manufacturer details
- Product characterization
- Intended purpose
- Variants and models
- MDR conformity assessment route
- Novel features
- Other similar devices on the market
- Product history
- Label and information provided
- Design, redesign and manufacturing
- General safety and perfomance requirements
- Applicable standards and regulations
- Risk management
- Vigilance system
- Post-market surveillance
- Product verification and validation
- Non-applicable requirements
- Suppliers and subcontractors
- Provision of service
- Technical assistance service
- Traceability
- Bill of materials (BOM)
- Key materials
Manufacturer details
| Manufacturer data | |
|---|---|
| Legal manufacturer name | AI Labs Group S.L. |
| Address | Street Gran Vía 1, BAT Tower, 48001, Bilbao, Bizkaia (Spain) |
| SRN | ES-MF-000025345 |
| Person responsible for regulatory compliance | Alfonso Medela, María Diez, Giulia Foglia |
| office@legit.health | |
| Phone | +34 638127476 |
| Trademark | Legit.Health |
Product characterization
We characterize the medical device in detail in the Legit.Health Plus Description and specifications_2023_001 document that includes the principle of operation of the device, intended users and patient population, contraindications and warnings and technical features, among others. Below we show the main characterization information.
| Information | |
|---|---|
| Device name | Legit.Health Plus (hereinafter, the device) |
| Model and type | NA |
| Version | 1.0.0.0 |
| Basic UDI-DI | 8437025550LegitCADx6X |
| Certificate number (if available) | MDR 792790 |
| EMDN code(s) | Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software) |
| GMDN code | 65975 |
| Class | Class IIb |
| Classification rule | Rule 11 |
| Novel product (True/False) | FALSE |
| Novel related clinical procedure (True/False) | FALSE |
| SRN | ES-MF-000025345 |
Intended purpose
This section contains a short summary of the device. A complete description of the intended purpose, including device description, can be found in Legit.Health Plus description and specifications 2023_001.
Product Description
The device is computational software-only medical device leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures. Its principal function is to provide a wide range of clinical data from the analyzed images to assist healthcare practitioners in their clinical evaluations and allow healthcare provider organisations to gather data and improve their workflows.
The generated data is intended to aid healthcare practitioners and organizations in their clinical decision-making process, thus enhancing the efficiency and accuracy of care delivery.
The device should never be used to confirm a clinical diagnosis. On the contrary, its result is one element of the overall clinical assessment. Indeed, the device is designed to be used when a healthcare practitioner chooses to obtain additional information to consider a decision.
Intended Purpose
The device is a computational software-only medical device intended to support health care providers in the assessment of skin structures, enhancing efficiency and accuracy of care delivery, by providing:
- quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others
- an interpretative distribution representation of possible International Classification of Diseases (ICD) classes that might be represented in the pixels content of the image.
Variants and models
The device does not have any variants. It is a unique model.
MDR conformity assessment route
We follow the Annex IX, I and III (part II of annex IX does not applied, according the risk classification of the device) route of the MDR 2017/745.
Novel features
The device incorporates AI, more precisely, deep learning. It is properly described at the Legit.Health Plus Description and specifications_2023_001.
As we explained at the R-002-007 Process validation card 2023_012, deep learning has the ability to analyze complex and large-scale medical datasets. It also enables our medical device to recognize patterns and make accurate predictions, leading to improved diagnostic capabilities for skin diseases. By leveraging this advanced technology, our device can offer more reliable results, better treatment recommendations, and enhanced patient outcomes. Additionally, deep learning's success in various applications makes it a valuable tool to streamline our manufacturing process, ensuring that our medical device meets the highest standards of quality and safety in the medical industry.
Other similar devices on the market
There are several similar devices on the market, but they are mainly focused on serving patients directly; whereas our approach is to help HCPs help their patients. We have studied them and compiled the main ones at the R-TF-007-002 Post-Market clinical follow-up (PMCF) Plan_2023_001, that are:
- Dermengine: that is a support tool to the diagnosis of skin cancer.
- Fotofinder hadyscope pro app: that is intended for patient management, standardized documentation of skin microimages, and to assist in the initial assessment of skin diseases.
- Skinscreener: a mobile application intended to perform skin lesions' risk assessment on iOS mobile devices, using the device's camera and a flashlight. The app analyses the images of skin lesions and returns the risk assessment calculated by an on device ML algorithm. Additionally, the user is remembered to perform an annual dermatological examination.
- Skinvision: The SkinVision Service allows users to take and submit photos of skin lesions for assessment, and gives a skin cancer risk indication associated with the specific lesion, detailing whether it is recommended to visit a specialized healthcare professional for further examination of the lesion, or to keep monitoring the lesion within the Standard Of Care. The application also facilitates keeping track of skin lesions, and provides information on the photographed lesions that may be used when seeking professional healthcare advice.
- Triage: It is intended to support patients in the early detection as well as monitoring of skin conditions. Triage provides up to five most likely conditions ranked in order of likelihood to support patients in their decision to seek for further professional assessment. For healthcare professionals Triage is intended to be used as a second opinion to support the diagnosis of skin conditions as well as to allow an initial remote triaging assessment in order to determine further necessary courses of action.
Product history
Previous generation
The predecessor of the current device was named Legit.Health. This earlier version was designed to provide a standalone interface as well as an API, allowing users to engage with it independently of their existing Electronic Health Records. However, this design direction was later recognized as suboptimal, as most organizations expressed a preference for integrating the device's functionalities directly into their existing systems.
In other words: the new generation differs from the previous device in that it's meant to integrate into organisation's softwares. It is used server-to-server, by computer programs. This means that the new device is simpler and contains less elements. This design allows us to focus on other issues, such as interoperability and documentation. And it allows us to invest our development efforts into the scalable architecture of the device, the structure of the input and the output, and helping customers during the integration process.
We first launched the previous generation of our device at the close of 2020, right after securing our manufacturing license in Spain. Since that time, we've partnered with 21 diverse customers. The customers span from goverment-run care providers to for-profit care providers. Over this period, more than 4,500 diagnostic reports have been crafted by more than 500 professionals. They've utilized our product to help over a thousand patients.
Summary of design stages
The stages of the design of the device overlap with the design and development of the previous generation. Keep in mind that the current device is an improvement, and also a simplification of the previous device.
The following chart shows a summary of the design stages.
Dates after the release of this document are forecasts, obviously.
In addition, we have participate in several clinical trials as it is shown in the following diagram (extracted from the R-TF-015-008 Clinical development plan) which also speak to the design and development process:
Regulatory information
We obtained the Spanish manufacturing license on 24th November 2020 to manufacture dermatology support software based on computer-assisted diagnosis.
Both devices are a tool that healthcare professionals use to help diagnose different dermatological conditions included in its intended use.
According to Directive 93/42/EC, Rule 12 applies and therefore they are Class I devices, and we released the first version of the previous generation of the device and also issued the Declaration of Conformity for the aforementioned device following this Directive by December 2020. This Declaration of Conformity is valid until December 2028 according to the updated transition period published by the 2023/603 European Regulation.
According to Chapter I of the Annex VII of the 2017/745 MDR section 2.5, our new device is an Active device, as it is intended for diagnosis and monitoring: it is used to supply information for diagnosing and monitoring dermatological conditions. Additionally, according to section 6 for the active devices, rule number 11 is selected as the most representative for the product features and specifications due to its software nature.
Label and information provided
As we detail at the GP-001 Control of documents we have prepared and validated the corresponding Instruction for Use and label for the device following the applicable regulation. Evidence of validation are available in the record R-TF-001-006 IFU and label validation.
The label of the device is available in the following record R-TF-001-008 Legit.Health Plus label while the Instructions for Use (IFU) are available at the following link: https://apidocs-draft.legit.health/.
Once the device is certified, we will release the IFU in our website as per procedure GP-001 Control of documents.
Design, redesign and manufacturing
Quality system certificate
Currently, we are being certified under EN ISO 13485:2016 and the selected route of conformity of the medical device has been selected under this consideration.
Technical description of the product
The device described in this Summary of Technical Documentation (STED) is designed and manufactured in such a way that, when used under the normal conditions and for the intended purpose, it will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
We describe the design and development process at the GP-012 Design, Redesign and Development to comply with the characteristics and benefits of Annex I (General safety and performance requirements, GSPR) of MDR 2017/745. The list of GSPR (R-TF-008-001 GSPR 2023_001) identifies collected documents and data to demonstrate the conformity of the product.
In R-TF-012-006 Legit.Health Plus life cycle plan and report_2023_001, we include a requirements matrix to demonstrate conformity with MDR 2017/745 and the harmonized standard EN ISO 13485:2016 (Design and Development).
All the details on the device design and development process are properly registered at the DHF of the product, as it is also explained at the R-TF-012-006 Legit.Health Plus life cycle plan and report_2023_001 record. It includes all the process involved in the software life cycle, as requirements, tests, verifications, validations, change control and releases.
The main steps on the product development can be reviewed in the following flowchart, which also points out at the templates used on each step and recorded in the Design History File:
General safety and perfomance requirements
The applicable General Safety and Performance Requirements (GSPR) used for the preparation of this document are those reflected in the Annex I of the MDR 2017/745. As we have previously mentioned, we list and analyze all the GSPR in the R-TF-008-001 GSPR 2023_001 record, that also identifies collected documents and data to demonstrate the conformity of the product.
Applicable standards and regulations
Regulations
- Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices.
- Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
- Spanish Royal Decree 192/2023 on Medical Devices.
- Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices.
- Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed).
- Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices.
Common specifications
There are no common specifications applicable to the device.
Harmonized standards
- UNE-EN ISO 13485:2018/A11:2022 (EN ISO 13485:2016/A11:2021) Medical devices - Quality management systems - Requirements for regulatory purposes. Instead of the harmonized version, we implemented the UNE-EN ISO 13485:2018 (EN ISO 13485:2016).
Non-applicable requirements:
- 7.5.2. Cleanliness of the product: due to its nature of medical device software, it does not require cleaning.
- 7.5.3. Activities during installation: due to its nature of medical device software, it does not require a physical installation, but a service provision.
- 7.5.5. Particular requirements for sterile medical devices: due to its nature of medical device software, it is not a sterile product.
- 7.5.7. Particular requirements for the validation of sterilization processes and sterile barrier systems: due to its condition of non-sterility.
- 7.5.9.2. Particular requirements for implantable medical devices: due to its nature of medical device software, it is not an implantable product.
- 7.6. Control of the monitoring and measuring equipment: due to its nature of medical device software, it is not required for follow-up in terms of measuring.
- 8.3.4. Re-work: due to its nature of medical device software.
- UNE-EN ISO 14971:2020/A11:2022 (EN ISO 14971:2019/A11:2021) Medical devices - Application of risk management to medical devices. Instead of the harmonized version, we implemented UNE-EN ISO 14971:2020 (EN ISO 14971:2019). Full application.
- UNE-EN ISO 15223-1:2022 (EN ISO 15223-1:2021) Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. Full aplication.
- UNE-EN ISO 20417:2021 (EN ISO 20417:2021) Medical devices - Information to be supplied by the manufacturer.
- UNE-EN 62304:2007/A1:2016 (EN 62304:2006/A1:2015) Medical device software - Software life-cycle processes. Complete application of sections applicable to a Class B device according to this standard.
- UNE-EN 62366-1:2015/A1:2020 (EN 62366-1:2015/A1:2020) Medical devices - Part 1: Application of usability engineering to medical devices. Full aplication.
- UNE-EN ISO 14155:2021 (EN ISO 14155:2020) Clinical investigation of medical devices for human subjects - Good clinical practice. Full aplication.
According to the last Commission implementing decisions containing references to the harmonised standards that apply to us:
- Commission implementing decision (EU) 2021/1182
- Commission implementing decision (EU) 2022/6
- Commision implementing decision (EU) 2023/694
The most updated lists of the harmonised standards for medical devices drafted in support of the Regulation MDR 2017/745, have been published. Some of them are pending to be harmonized by the end of May 2024 as it was published by the European Commission at the commission implementing decision C(2021) 2406. Consequently, the current state (and its justification) of the applied standards in the Design and Development medical device process is shown below.
| Applied standard | Is it harmonised? | Justification of use | GAP analysis |
|---|---|---|---|
| EN ISO 13485:2016 | FALSE | The harmonized version includes 2 new Annexes (Annex ZA and Annex ZB) that link the requirements of the MDR and IVDR, respectively, to specific clauses of the standard. Amendment A11 does not modify the normative part of the referenced EN ISO 13485:2016, therefore we consider the implementation of the non-harmonized version adequate without posing compliant risks. | The harmonized version includes 2 new Annexes (Annex ZA and Annex ZB) that link the requirements of the MDR and IVDR, respectively, to specific clauses of the standard. Amendment A11 does not modify the normative part of the referenced EN ISO 13485:2016. |
| EN ISO 14971:2019 | FALSE | The harmonized version included additional Annexes (Annexes Z) that provide information about which parts of the legislation are addressed by the standard. Amendment A11 does not modify the normative part of the referenced EN ISO 14971:2019, therefore we consider the implementation of the non-harmonized version adequate without posing compliant risks. | The harmonized standard contains new Annexes (Annexes Z) that provide information about which parts of the legislation are addressed by the standard. Amendment A11 does not modify the normative part of the referenced EN ISO 14971:2019. |
| EN 62304:2006/A1:2015 | FALSE | It is a harmonized standard for MDD. According to Annex C.1, this standard is related with ISO 13485:2003. These relations between this standard and the new ISO 13485:2016 are analysed in the GAP analysis. The European commission has asked its harmonization, that is pending to be adopted by 27th May, 2024 | The chapter 5.1 of the EN 62304:2006 and A1:2015 is related with 7.3.1 of the ISO 13485:2003, that it is related with 7.3.2 of ISO 13485:2016 . The chapter 5.2 of the EN 62304:2006 and A1:2015 is related with 7.3.2 of the ISO 13485:2003, that it is related with 7.3.3 of ISO 13485:2016 . The chapter 5.7 of the EN 62304:2006 and A1:2015 is related with 7.3.3 and 7.3.4 of the ISO 13485:2003, that it is related with 7.3.4 and 7.3.5 of ISO 13485:2016 . The chapter 5.8 of the EN 62304:2006 and A1:2015 is related with 7.3.5 and 7.3.6 of the ISO 13485:2003, that it is related with 7.3.6 and 7.3.7 of ISO 13485:2016 . The chapter 6.1 of the EN 62304:2006 and A1:2015 is related with 7.3.7 of the ISO 13485:2003, that it is related with 7.3.9 and 7.3.7 of ISO 13485:2016 . The chapter 5.8 of the EN 62304:2006 and A1:2015 is related with 7.3.5 and 7.3.6 of the ISO 13485:2003, that it is related with 7.3.6 and 7.3.7 of ISO 13485:2016 . The chapter 8.1 of the EN 62304:2006 and A1:2015 is related with 7.5.3 of the ISO 13485:2003, that it is related with 7.5.8 and 7.5.9 of ISO 13485:2016 . The chapter 8.2 of the ISO 62304:2006 and A1:2015 is related with 7.5.3 of the ISO 13485:2003, that it is related with 7.5.8 and 7.5.9 of ISO 13485:2016 . The EN 62304:2006/A1:2015 is required and adequate |
| EN ISO 15223-1:2021 | TRUE | It has been harmonized according to the above-mentioned decision 2022/6. | Not required because we adopeted the harmonized version of the standard |
| EN 62366-1:2015/A1:2020 | FALSE | The previous version has been applied under MDD (EN 62366:2008). This version has been cancelled by EN 62366-1:2015, which is corrected by EN 62366-1:2015/AC:2015 and modified by EN 62366-1:2015/A1:2020 It has been applied to justify the achieving of several GSPR described at the 2017/745 MDR. These justifications are analysed in the GAP analysis. The European commission has asked its harmonization, that is pending to be adopted by 27th May, 2024 | It has been applied to justify the following GSPRs: #1, due to its intended performance is directly related with the user interaction with the product and the management of the risks related with human factors and the product usability. #4 due to risk control measures related with human factors must be adequate and efficient to warranty the safety principles and ensure the design's efforts. #6, in relation with a medical device software, the product lifetime is conditioned to the user's principles and their interactions. #14, the device is used server-to-server, by computer programs. Thus, no accesory is user directly in interaction with the device. #15, due to it is intended to provide information to support practitioners in decision making for diagnostic purposes. #17, this medical device is a software, so, it is necessary to analyse the relation human-machine to ensure an adequate understanding to evidence the safety and performance of the product. |
| EN ISO 14155:2020 | FALSE | The current version has been harmonized under MDD. It has been applied to justify the achieving of several GSPR. These justifications are analysed in the GAP analysis. The European commission has asked its harmonization, that is pending to be adopted by 27th May, 2024 | The chapters 4.1, 5.2 and 5.3 of the EN ISO 14155:2020 are related to ER 6a of the MDD, that it is related with the first GSPR of MDR, together with chapter VI, that requires the evidence for accomplishment of all applicable GSPR in terms of Safety and clinical performance. This standard is required and adequate. |
| EN ISO 20417:2021 | FALSE | Since ISO 20417:2021 is yet to be fully harmonized under the MDR, we use this standard as a guideline, prioritizing the MDR's requirements in case of any conflict. The European commission has asked its harmonization, that is pending to be adopted by May,2024 | EN ISO 20417:2021 addresses GSPR 1, that requires to provide the information about the safe use of the device. It also addresses GSPR 23, setting standard for the information that must be included with medical devices, and GSPR 20 & 21, including the mandatory inclusion of information such as the device's name, model number and manufacturer's details throughout the supply chain. Additionally, the ISO supports GSPR 14 by requiring that manufacturers provide information that includes any clinical data or evidence supporting the use and efficacy of the device, and clear instructions and information regarding the use of the device. |
Guidelines
- MEDDEV 2.4/1: Classification of medical devices.
- MEDDEV 2.1/6 Guidelines on the qualification and classification of stand alone software used in thealthcare within the regulatory framework of medical devices
- MEDDEV 2.7/1: Clinical evaluation. A guide for manufacturers and notified bodies.
- MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 - MDR and Regulation (EU) 2017/746 - IVDR.
- MDCG 2019-16: Guidance on Cybersecurity for medical devices.
- MDCG 2020-1: Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software.
- MDCG 2020-5: Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies.
- MDCG 2020-7: Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies.
- MDCG 2020-8: Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies.
- MDCG 2022-2021: Guidance on PSUR according to regulation (EU) 2017/745 (MDR)
- MDCG 2023-3: Questions and answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
- 2023/C 163/06: Content and structure of the summary of the clinical investigation report
- UNE-CEN ISO/TR 24971:2020: Medical devices. Guidance on the application of ISO 14971
Risk management
All risks associated with the medical device have been assessed. Risk mitigation measures have been implemented, verified and evaluated to calculate the final risk score after riks control implementation. The residual risk of the device is acceptable with respect to its intended purpose and proper use.
The analysis, evaluation and verification of the measures taken are carried out following the GP-013 Risk management, and we have established at the R-TF-013-001 Risk management plan the criteria regarding the risk acceptability, the risk evaluation and control procedure, the residual risks management and the procedure to perform the benefit-risk analysis.
During all life cycle stages of the device, we plan, execute, document and maintain the risk control process that is registered at the R-TF-013-002 Risk management record.
At least once a year, we elaborate a Risk Management Report (R-TF-013-003 Risk management report for the last period) with the activity of the risk management tasks of that year. The conclusions will serve as input for Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF), also taking information from the events identified by these.
Vigilance system
We have established a vigilance system described at the GP-004 Vigilance system. Any incident detected that may have an impact on the patients safety or manufacturing process will be reviewed and evaluated and we will take the appropriate measures, and notified to the regulatory authorities when required. When a non-conformity was detected, we will manage it according to the GP-006 Non-conformity. Corrective and preventive actions.
Post-market surveillance
As a measure of the effectiveness of the QMS implanted we obtain information of the accomplishment of the client requirements and to gain specific experience in the post-production phase, we have implemented the procedure GP-007 Post-market surveillance and created the corresponding records for the product:
R-TF-007-001 Post-Market Surveillance (PMS) Plan_2023_001R-TF-007-002 Post-Market clinical follow-up (PMCF) Plan_2023_001R-TF-007-003 Periodic Safety Update Report (PSUR) 2023_001R-TF-007-004 PMS evaluation report_2023_001R-TF-007-005 PMCF evaluation report_2023_001
Additionally, we also obtain information from the customers and their feedback and possible complaints, as we describe at the GP-014 Feedback and complaints procedure.
This information serves as a potential input to the risk management for the monitoring and maintenance of the applicable product requirements, both legislative and customer.
Product verification and validation
Preclinical and clinical data
Engineering tests
- Performance tests: they involve the periodic revision process we carry out throughout the whole product life cycle.
- Verification tests: they confirm that the medical device works adequately based on its technical specifications after every modification.
- Validation tests: they confirm that the medical device works as expected based on its intended use.
All the results and records from the mentioned tests are registered at the corresponding Legit.Health Plus DHF.
We have also created an specific plan for the device usability testing (R-TF-012-007 Formative evaluation plan_2023_001 and R-TF-012-014 Summative evaluation plan_2024_001) with its corresponding reports (R-TF-012-008 Formative evaluation report_2023_001 and R-TF-012-015 Summative evaluation report_2024_001).
Clinical evaluation
The clinical evaluation of the product is performed according to the procedure GP-015 Clinical evaluation.
It mainly involves:
- State of the art analysis: The analysis of the preclinical and clinical background, current knowledge and state of the art is crucial to understand the technological context, the natural course of conditions, and the alternative available treatment options around which the medical device is developed.
- Similar devices: analysis of devices that has similar intended purpose with common technology.
- Device equivalence: comparison between our device with a device without clinically significant differences in the safety and clinical performance.
- Clinical investigation: we have performed several clinical investigations to confirm the clinical benefits of our product.
All the clinical evaluation regarding the device is registered in the corresponding device Technical File in the following documents:
R-TF-015-001 Clinical Evaluation Plan_2023_001R-TF-015-002 Preclinical and clinical evaluation record_2023_001R-TF-015-003 Clinical Evaluation Report_2023_001
Non-applicable requirements
- Biocompatibility and biological safety
- Cleaning and disinfection
- Chemical, physical and biological properties
- Packaging
- Sterilization
Suppliers and subcontractors
The suppliers selection and evaluation is performed according to our GP-010 Purchases and suppliers evaluation and the result of the evaluation is registered at the R-010-001 Suppliers evaluation 2023_001.
Provision of service
When a new contract is signed according to the procedure GP-009 Sales, we start the service provision to the client following the GP-011 Provision of service procedure.
Due to the software nature of the device, the production phase of the device does not start when a client request the product. Instead, the product is already developed, tested, validated and released according to the GP-012 Design, redesign and development.
Technical assistance service
We also provide the users the corresponding technical service as we described at the GP-017 Technical Assistance Service procedure.
Traceability
We ensure the traceability of the product following the procedure GP-016 Traceability and identification, being our main goal that all customers use latest version of the medical device.
Bill of materials (BOM)
The 'materials' of our software medical device are quite different from a traditional hardware medical device. They involve software components, infrastructure, and data, all of which must be managed and maintained to ensure the device's effectiveness and compliance with regulations.
We include the bill of materials within the R-TF-012-006 Legit.Health Plus life cycle plan and report_2023_001 as the detailed, formal description of the software components used to build our device. This includes the source code, frameworks, and other software that the product relies on.
It is worth mentioning that, once the device is manufactured, the finished device does not rely on third party software or libraries, because all the code is developed in-house and deployed as a whole to the server. During the development and the training of the processors, we do use other programs for different tasks, but once its developed, the scripts do not rely on 3rd party materials.
Key materials
As the device is purely software, its materials are the components of the architecture of the software, the infrastructure supporting it, and the data it processes.
The following table summarizes the materials used by each of the components of the device - for more information about the components of the device, please refer to the record Legit.Health Plus description and specifications_2023_001.
| Component | Materials | Languages |
|---|---|---|
| HTTP API | JSON data, HTTP protocol, Server instance | HTTP, JSON |
| Processors | JSON data, Server instance | JSON, Python |
| Orchestrator | JSON data, Server instance | JSON, Python |
| Report builder | JSON data, Server instance | JSON, Python |
JSON data
The device inputs JSON data. The JSON data is the only thing that the device inputs. Not only that, but the JSON data is the only thing that travels between the components. Finally, the output of the device, built by the ReportBuilder, is JSON data. One may argue that the JSON data is the key material of device.
JSON (Javascript Object Notation) is an open standard file format and data interchange format that uses human-readable text to store and transmit data objects consisting of attribute-value pairs and arrays. It is a common data format with diverse uses in electronic data interchange, including that of web applications with servers.
Applicable standards
- ECMA-404: JSON was first standardized in 2013, as ECMA-404.
- ISO/IEC 21778:2017: in 2017, JSON was also standardized as ISO/IEC 21778:2017.
- RFC 8259: is the current version of the Internet Standard STD 90
The ECMA and ISO/IEC standards describe only the allowed syntax, whereas the RFC covers some security and interoperability considerations.
Server instance
The device must be made available via the internet, which means that is must be hosted on servers, which can be considered a material of the device. As such, the servers' specifications, processing power, memory, and storage, are relevant to the availability of the device. Our supplier for the server is defined in the R-010-001 Suppliers evaluation as part of the GP-010 Purchases and suppliers evaluation. Furthermore, this issue is defined in GP-018 Infrastructure and facilities.
HTTP Methods
The device is accessed via a HTTP API that follows the REST guidelines.
HTTP is an extensible protocol that is easy to use. Its the main protocol for exchanging information in the Internet. Technically, HTTP can be defined as a stateless application-level protocol for distributed, collaborative, hypertext information systems.
REST guidelines suggest using a specific HTTP method on a particular type of call made to the server. In the case of the device, the supported methods are: GET, and POST. Request methods are considered safe if their defined semantics are essentially read-only.
Consideration about key materials
Compliance with Regulations
Given that the device processes personal health data, it must comply with regulations regarding data protection and privacy, such as the GDPR in the EU. This compliance extends to all 'materials' used in the device, including the software components, infrastructure, and data.
Intellectual Property
The software components that we develop, and especially the processors, could be considered intellectual property in certain jurisdictions. As such, we consult with IP firms and maintain proper protections in place for our inventions.
As well as this, we conduct freedom to operate studies, where we ensure that none of the elements of our device collide with other inventions.
Software Quality Assurance
As a medical device, the software must meet high standards for quality and reliability. This requires rigorous software testing and quality assurance processes.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001