R-TF-013-003 Risk management report

Intended use and identification of the qualitative and quantitative characteristics

The following questions, extracted from Annex A.2 of UNE-CEN ISO/TR 24971:2020, help us identifying all the characteristics of the medical device manufactured that could affect its safety and performance. The list is neither exhaustive nor representative and must be appropriate to the medical device in question, and we will skip the questions that are not relevant to it.

#	Characteristics of the medical device that could affect safety	Applicable?	Justification	Section of the risk analysis where have been evaluated & risk identify
1	What is the intended use and how is the medical device to be used?	TRUE	The intended purpose is to support clinicians during the dermatosis diagnosis process, through the medical information provided by the device as a result of skin structure image processing and analysis. This process contributes indirectly to a faster, more efficient and affordable diagnosis, and to more continuous and objective monitoring of the severity of the condition, especially in what regarding telemedicine.	Product and requirements. Risks 1, 2, 3, 4, 11, 13, 16, 24, 31, 36.
2	Is the medical device intended to be implanted?	FALSE
3	Is the medical device intended to be in contact with the patient or other persons?	FALSE
4	What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device?	FALSE
5	Is energy delivered to or extracted from the patient?	FALSE
6	Are substances delivered to or extracted from the patient?	FALSE
7	Are biological materials processed by the medical device for subsequent reuse, transfusion or transplantation?	FALSE
8	Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?	FALSE
9	Is the medical device intended to be routinely cleaned and disinfected by the user?	FALSE
10	Does the medical device modify the patient environment?	FALSE
11	Are measurements taken?	FALSE
12	Is the medical device interpretative?	FALSE
13	Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?	FALSE
14	Are there unwanted outputs of energy or substances?	FALSE
15	Is the medical device susceptible to environmental influences?	FALSE
16	Does the medical device influence the environment?	FALSE
17	Does the medical device require consumables or accessories?	TRUE	The device is a standalone software (API rest) that requires to be integrated into the user servers.	Product and requirements. Risks 1, 2, 3, 4, 11, 13, 16, 19, 31, 36.
18	Is maintenance or calibration necessary?	TRUE	Maintenance activities on the Application Programming Interface (API) are performed on a yearly basis.	Risks 48, 49, 50
19	Does the medical device contain software?	TRUE	The device is a standalone software, more precisely is an API (Automatic Programming interface)	Essential requirements. Risk 20
20	Does the medical device allow access to information?	TRUE	The device allows the users to collect the results of the images' analysis and it also allows to check previous results to ensure the proper monitoring of the condition	Product and infrastructure. Risks 5, 6, 7, 8, 14, 15.
21	Does the medical device store data critical to patient care?	TRUE	The device stores anonymous data: images of the conditions and optionally gender, heigth, weigth and birthday.	Requirements. Risks 26, 29.
22	Does the medical device have a restricted shelf life?	FALSE	Given the nature of the product (API), it has no shelf life limitation.	Requirements. Risk 51
23	Are there any delayed or long-term use effects?	FALSE
24	To what mechanical forces will the medical device be subjected?	FALSE
25	What determines the lifetime of the medical device?	FALSE	Given the nature of the product (API), it has no lifetime limitation.	Requirements. Risk 51
26	Is the medical device intended for single use?	FALSE
27	Is safe decommissioning or disposal of the medical device necessary?	FALSE
28	Does the installation or use of the medical device require special training or special skills?	TRUE	Our medical devices require a team of IT experts on the customer side or to contract our services to perform the integration into user's softwares.	Product integration. Risks 19, 36.
29	How will information for safety be provided?	TRUE	Safety information is shared with the customers through the IFU	Requirements. Risk 28
30	Are new manufacturing processes established or introduced?	TRUE	We introduce software artificial intelligence manufacturing process	Requirements. Risk 52
31	Is successful application of the medical device dependent on the usability of the user interface?	TRUE	The device is integrated via API into third party softwares, which means that interaction with the medical device capabilities happens programmatically: server-to-server.	Product integration. Risks 1, 2, 3, 4, 11, 13, 31
31.1	Can the user interface design features contribute to use error?	FALSE	The application programming interface (API) has been designed to avoid use error.	Product. Risks 1, 2, 3, 4, 22
31.2	Is the medical device used in an environment where distractions can cause use error?	FALSE	No, because of its asynchronous nature. The operation of the device does not require real time interactions. The user submits a picture and receives a report that is static, not requiring actions. Its not interactive.
31.3	Does the medical device have connecting parts or accessories?	TRUE	Mainly three types of accessories: 1) image capture devices, such as smartphones, 2) browsing devices, such as computers, and 3) User interface to visualise the report. The first two are hardware, whlist the other is software	Requirements. Risk 25
31.4	Does the medical device have a control interface?	FALSE	The device is used through an API (Application Programming Interface). This means that the interface is coded, and used programatically, without a user interface.
31.5	Does the medical device display information?	FALSE	Not to the user, the medical device returns the image analysis results in a json format that is read programmatically.	Product integration. Risks 1, 2, 3, 4, 31, 36.
31.6	Is the medical device controlled by a menu?	FALSE	The device is used through an API (Application Programming Interface). This means that the interface is coded, and used programatically, without a user interface.	Product integration. Risks 1, 2, 3, 4, 11, 13, 19, 31, 36.
31.7	Is the successful use of the medical device dependent on a user's knowledge, skills and abilities?	TRUE	It depends on two kinds of users: The technicians that integrate the device into their system, that must have the knowledge to do it The health care practitioners that must have been trained on its usage	Product and training. Risks 17, 18, 19, 36, 41
31.8	Will the medical device be used by persons with special needs?	FALSE
31.9	Can the user interface be used to initiate unauthorised actions?	FALSE	Only the authorized computer has the API key, and the API key has been delivered securely following our GP-011 Provision of service.	Data privacy requirements. Risks 26, 29.
32	Does the medical device include an alarm system?	TRUE	The device send alerts to the user when there is any problem with the communication between the device and the user end.	Infrastructure. Risks 11, 12, 13, 14, 15.
33	In what ways could the medical device be misused (deliberately or not)?	TRUE	Due to security issues, such as API key sharing, and due to technical issues, such as wrong images formats or resolution.	Requirements and product. Risks 9, 26, 30, 40, 41, 54.
34	Is the medical device intended to be mobile or portable?	FALSE	The device is used through an API (Application Programming Interface). This means that the interface is coded, and used programatically, without a user interface.
35	Does the use of the medical device depend on essential performance?	FALSE	It is a clinical decision support tool and because it is a software that doesn't interact with patients directly.
36	Does the medical device have a degree of autonomy?	TRUE	Low degree of autonomy. The device has the autonomy to analyze the images received and export the analysis results when receiving the order to do so.	Requirements and product. Risks 9, 14, 34, 35, 54.
37	Does the medical device produce an output that is used as an input in determining clinical action?	TRUE	The device provides the practitioner with images data analysis results that can be used for the triage and diagnosis, treatment and follow up of the patients conditions.	Product and requirements. Risks 5, 6, 7, 24.

List of generic hazards applicable to this product family

Associated with energy sources	Applicable	Justification
Electricity	FALSE
Heat, surface temperature	FALSE
Mechanical strength	FALSE
Ionizing radiation	FALSE
Electromagnetic fields	FALSE
Moving parts (motorized)	FALSE
Suspended masses	FALSE
Failure of patient support system	FALSE
Pressure	FALSE
Sound pressure (noise)	FALSE
Vibrations	FALSE
Magnetic fields	FALSE

Biological	Applicable	Justification
Biological overload	FALSE
Incorrect release of substances or energy	FALSE
Incorrect formulation (chemical composition)	FALSE
Biocompatibility and toxicity	FALSE
Infection and biological contamination	FALSE
Difficulty in maintaining hygienic safety	FALSE
Degradation	FALSE

Associated with the environment	Applicable	Justification
Electromagnetic interference	FALSE
Inadequate supply of energy or cold	FALSE
Restriction of ventilation, perspiration	FALSE
Probability of operation in adverse environmental conditions	FALSE
Incompatibility with other devices	TRUE	The requirements of the user end are defined at the IFU to ensure the proper operating of the device
Accidental mechanical damage to the product	FALSE
Pollution (waste and removal)	FALSE
Corrosion	FALSE
Flammability	FALSE

Relative to the use of the product	Applicable	Justification
Inadequate labelling	TRUE	We have designed the proper labelling according to requirements and the nature of our product as it is recommended at the MDR 2017/745 Annex I Chapter III section 23 and the Annex 6 part C section 6.5 for the software as medical devices
Inadequate instructions for use	TRUE	We have designed the IFU according to requirements and the nature of our product as it is recommended at the MDR 2017/745 Annex I Chapter III section 23
Inadequate specification of accessories	TRUE	We have designed the IFU according to requirements and the nature of our product as it is recommended at the MDR 2017/745 Annex I Chapter III section 23, including the medical device's accessories specifications requirements.
Inadequate specification of pre-use checks	FALSE
Complicated instructions for use	TRUE	We have designed and written the IFU in a friendly, intuitive and simplified version to allow their proper usage.
Instructions for use not available or separate from the product	TRUE	As our medical device is a software, we have designed electronic IFU that are available electronically
Use by untrained personnel	TRUE	There are two situations: the device is used by non-HCP (health care professionas) or integrated by untrained technicians. We have included at the IFU that the intended user must be a health care professional and we only give access to health care providers. We also specify the technologies that intervene in the integration.
Reasonably foreseeable misuse	TRUE	We have considered all the reasonably foreseeable misuses detected, including the ones detected during our legacy device usage.
Inadequate warning of adverse effects	TRUE	It is not known or foreseen any undesirable side-effects specifically related to the use of the software, as it is explained at the IFU
Inadequate warning of possible hazards in case of reuse of single-use products	FALSE
Incorrect measurement and other metrological aspects	FALSE
Incorrect diagnosis	TRUE	The device must always be used for reviewing the results by a dermatologist. In the event of an incorrect diagnosis provided by the device, the specialist that review the image analysis results can validate if the result is correct, or chose the proper one from the conditions list provided and validate this new condition, to ensure the patient is properly diagnosed.
Wrong data transfer	TRUE	The device must be properly connected server-to-server via API REST to allow proper data transfer. We describe the procedure to connect the manufacturer organization server with the API in the IFU.
Misinterpretation of results	TRUE	The device must be properly integrated in the Management Organization system by trainned technicians according to our IFU. Additionally, the results shown by this system always be used for reviewing the results by a dermatologist properly trained on the device usage
Incompatibility with consumables, accessories or other devices	TRUE	Given the nature of our device, the compatibility with the devices that are communicating with the API are considered during the Design and Development phase and the proper advise is noted down at the IFU to ensure the users connect and integrate the device properly.
Forces, inadequate contact pressures	FALSE
Imprisonment of parts of the human body	FALSE
Non-functional edges, surfaces or cutting edges	FALSE
Discomfort of use and handling (ergonomics)	FALSE

Associated with functional failure, maintenance and aging of the product	Applicable	Justification
Inadequate to the planned functions	TRUE	API maintenance is performed yearly when its validation is performed to ensure its proper operating. No additional maintenance is required.
Inadequate or absent maintenance specifications, including performance checks	TRUE	The device does not require any performance checks activities nor maintenance by the users, as it is specified at the IFU.
Inadequate maintenance	TRUE	API maintenance is performed yearly when its validation is performed to ensure its proper operating. No additional maintenance is required.
Absence of limitation of product lifetime	TRUE	Given the nature of the product (API), it has no lifetime limitation.
Loss of mechanical integrity	FALSE
Inappropriate packaging (loss of sterility, contamination or deterioration of the product)	FALSE
Incorrect reuse	FALSE
Cutting edges due to breakage	FALSE

Benefit-risk ratio acceptability

The benefit-risk analysis is based on individual and global risks considerations:

Individual

When a risk is evaluated as AFAP and no further actions can be implemented, it requires a benefit-risk analysis. The following risks have been evaluated as "AFAP":

#	Hazard	Hazardous situation
5	Incorrect clinical information	The care provider receives into their system data that is erroneous
6	Incorrect diagnosis or follow up	The medical device outputs a wrong result to the HCP
9	Image artefacts/resolution	The medical device receives an input that does not have sufficient quality in a way that affects it performance
11	Data transmission failure from care provider's system	The care provider's system cannot connect to the device to send data
12	Data input failure	The medical device cannot receive data from care providers
13	Data accessibility failure	The care provider cannot receive data from the medical device
14	Data transmission failure	The medical device cannot send data to care providers
30	The user is unable to provide adequate lighting conditions	The medical device receives an input that does not have sufficient quality

Control state of the risks

Risk control measures have been implemented for all risks identified in the R-TF-013-002 Risk Management Record_2023_001 and the current state of risks control verifies that ALL FORESEEABLE RISKS ARE CONTROLLED AND MITIGATED according to R-TF-013-002 Risk Management Record_2023_001.

The resulting individual residual risks are classified as:

• Acceptable: when mitigation measures have been implemented and no further actions are required for the safe use of the device
• AFAP (as far as possible): when mitigation measures have been implemented and an individual benefit-risk analysis is required.

The individual benefit/risk analysis for AFAP risks is conducted as specified in the internal procedure GP-013 - Risk management, and it is confirmed by the benefit/risk ratio analysis performed below and confirmed and documented at the R-TF-015-003 Clinical evaluation report (CER). All AFAP risks are currently controlled, but PMS and PMCF data will confirm a minimization.

#	Hazard	Hazardous situation	Benefit-risk analysis
5	Incorrect clinical information	The care provider receives into their system data that is erroneous	Benefits outweigh the risks
6	Incorrect diagnosis or follow up	The medical device outputs a wrong result to the HCP	Benefits outweigh the risks
9	Image artefacts/resolution	The medical device receives an input that does not have sufficient quality in a way that affects it performance	Benefits outweigh the risks
11	Data transmission failure from care provider's system	The care provider's system cannot connect to the device to send data	Benefits outweigh the risks
12	Data input failure	The medical device cannot receive data from care providers	Benefits outweigh the risks
13	Data accessibility failure	The care provider cannot receive data from the medical device	Benefits outweigh the risks
14	Data transmission failure	The medical device cannot send data to care providers	Benefits outweigh the risks
30	The user is unable to provide adequate lighting conditions	The medical device receives an input that does not have sufficient quality	Benefits outweigh the risks

Global

It is assessed in consideration of the product features and its R-TF-015-003 Clinical evaluation report (CER). Global benefit/risk ratio is acceptable, according to the CER conclusions:

Benefits

Clinical advantages

The device offers precision in analyzing skin structures, contributing significantly to improve clinical outcomes. The non-invasive nature of the device ensures patient safety while providing healthcare practitioners with a wealth of data to aid in their clinical evaluations.

Efficiency and workflow improvement

By seamlessly integrating into existing healthcare workflows, the device enhances operational efficiency, reduces patient wait times, and optimizes resource utilization within healthcare organizations.

Support for longitudinal monitoring

The ability to track the progression of skin conditions over time allows for more personalized and effective patient care, as well as providing invaluable data for long-term clinical studies.

Preliminary diagnostic assistance

Our device offers preliminary interpretative distribution representation of possible ICD categories, aiding in the initial stages of patient evaluation and contributing to a more streamlined diagnostic process.

Risks and undesirable side-effects

While the device presents clinical benefits, it is crucial to remain cognizant of potential risks and undesirable side-effects.

Data privacy and security

As a software device handling sensitive patient data, ensuring the utmost data privacy and security is paramount. Any breach or misuse of data could have severe implications for patient privacy and trust in the device.

Over-reliance on the device

There is a potential risk of healthcare practitioners becoming overly reliant on the device, potentially neglecting other crucial aspects of patient evaluation. It is vital to reinforce that our device is intended to be an aid in the clinical decision-making process, not a replacement.

Misinterpretation of data

The risk of misinterpretation, which could lead to incorrect clinical decisions, has been mitigated by designing the endpoints of the device in accordance with the FHIR interoperability standard and by providing detailed IFU to ensure correct interpretation and application of data. Despite these control measures, the risk of data misinterpretation warrants continuous monitoring. Therefore, it is recommended that this hazard be reviewed and assessed continuously during the post-market surveillance phase to ensure ongoing safety and effectiveness of the device.

Acceptability of Benefit-Risk ratio

Criteria for acceptance

Our acceptable benefit-risk profile hinges on the device demonstrating clear clinical advantages, efficiency improvements, and support for longitudinal monitoring, with minimal risks associated with data security, over-reliance, and data misinterpretation.

• Clinical safety: No adverse effects should be found in preclinical data evaluation, and a positive impact on algorithm performance and user feedback should be evident (as per PMCF activities 2 and 4).
• Literature support: Current literature should support the use of AI in the manufacturing process, highlighting the clinical benefits and advantages over existing alternatives.
• Risk management: A comprehensive risk management plan (GP-013 Risk management) is in place, ensuring all known and foreseeable risks are evaluated and mitigated.

Target populations and clinical contexts

The device is designed for use across all age groups, skin types, and demographics, ensuring wide applicability. It is imperative that the benefits and risks are carefully weighed in these diverse clinical scenarios to maintain a favorable benefit-risk ratio.

Professional opinions and unmet medical needs

Diverging opinions among healthcare professionals regarding the use of computational devices in clinical settings necessitate clear communication of the device's benefits and limitations. Addressing unmet medical needs, particularly in the realm of dermatological assessment, remains a top priority.

Overall residual risk

In conclusion, our computational medical device presents a highly favorable and acceptable benefit-risk ratio, with its myriad of clinical benefits significantly outweighing the potential risks and undesirable side-effects. Continuous monitoring during the post-market phase, proper customer support, and adherence to data privacy and security protocols are essential to maintaining this balance and ensuring the ongoing safety and efficacy of the device.

Risk management review

The risk management process has been reviewed according to GP-013 Risk management procedure before the device commercialization, guaranteeing that:

• The R-TF-013-001 Risk Management Plan has been appropriately executed.
• The overall residual risk is acceptable.
• Appropriate methods are in place to collect and review relevant production and post-production information.

Record signature meaning

• Author: JD-004
• Reviewer: JD-003
• Approval: JD-005