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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-016 Traceability and identification

GP-016 Traceability and identification

Purpose​

To describe the methodology to establish the general rules that allow the identification of the product status, as well as to determine the procedure to guarantee the traceability of the finished product.

Scope​

All the medical devices that we manufacture.

Definitions​

  • EMDN: European Medical Device Nomenclature
  • GMDN: Global Medical Device Nomenclature
  • UDI: Unique Device Identifier. The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
  • UDI-DI: UDI device identifier. The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
  • UDI-DI basic: The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
  • UDI-PI: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.

Responsibilities​

JD-001​

To provide the organization and its members with the necessary resources to carry out their obligations in the most efficient way possible.

To validate the sales forecast and the necessary product availability.

JD-005​

To identify the status of the existing devices and the correct allocation of the UDI number and software versions to the manufactured products according to the coding system described in this document.

To release the finalized products.

JD-003​

To define the state identification of the product and to organize the product development team to ensure the products are developed according to the establish procedures described within the Quality Management System.

JD-004​

To elaborate the system of identification of the state of the product, to ensure the product development team register all the production records according to the established procedures and to review these records to guarantee the traceability of the manufactured products.

Inputs​

  • Contracts with clients signed
  • T-011-001 API key order

Outputs​

  • T-012-012 Customers product version control

Development​

As it is specified at the 2017/745 Medical Devices European Regulation, we include within each product that we manufacture its corresponding label with the requirements detailed in the mentioned regulation and listed at the GP-001 Documents and records control.

Some of these requirements are the following specific codes:

  • Serial number
  • Manufacturing date
  • UDI-DI
  • GMDN code
  • EMDN code

Product serial number and UDI assignment​

Each product developed or placed on the market will have a serial number corresponding to the identification of the engineering level that is the software version released, that will be indicated at the corresponding T-012-004 Version release.

Manufacturing date​

The manufacturing date of each product will be the release date indicated at the corresponding T-012-004 Version release.

UDI​

To comply with the Article 27 of the 2017/745 MDR, all of our products will be properly identified with the corresponding UDI code, which will collect the information necessary to trace the product.

As we have previously described, the UDI (see below) is comprised of the UDI-DI and the UDI-PI:

  • The UDI-DI will be assigned by the Spanish Representative of the Global Organization GS1 AECOC, authorized to generate these codes.
  • The UDI-PI will be comprised by the manufacturing date plus the version of the software

The codes will be represented as follows:

  • UDI-DI: (01)XXXXXXXXXXXX
  • Version: (21)X.X
  • Manufacturing date(11): YYYYMMDD
  • UDI: (01)XXXXXXXXXXXX (11)YYYYMMDD(21)X.X

EMDN code​

As established at the Article 26 of the 2017/745 Medical Devices European Regulation, to facilitate the functioning of the European database on medical devices (Eudamed), each product or family of products manufactured will be identified with their corresponding EMDN code according to the European Commision list.

GMDN code​

The Global Medical Device Nomenclature (GMDN) is a comprehensive set of terms, within a structured category hierarchy, which name and group all medical device products including implantables, medical equipment, consumables, and diagnostic devices.

As our product will be also commercialized outside the European Union, we will include the corresponding GMDN code along with the product label to comply with the applicable regulations.

Traceability​

Due to the nature of the products we manufacture, we do not need to consider batches and quantities of the products distributed. As it is specified at the GP-012 Design, redesign and development procedure, we need to focus our traceability control to the version of the medical device that our customers are using. In fact, one of our goals is that all customers use latest version of the medical device. Once a new version is released, the Technical Director JD-005 is the person in charge of contacting customers to ensure that they transition to it.

As this new version is an improved one, we consider that all customers use the latest version of the product by default. However we keep a record of customers that have not transitioned to the new versions in the corresponding T-012-012 Customers product version control document, that we update yearly. The purpose of this record is to fulfil the goal and to implement a mitigation measure for the related risk.

In case of an incidence or recall need, we review the information of which version is each customer using in the server itself, not on this record, to ensure the customers affected are properly identified.

Productive state identification​

According to the nature of our medical devices, we do not require to identify any non-conforming products, as the software are not released until the verification and validation procedures had been performed with satisfactory results as we specify at the GP-012 Design, redesign and development procedure.

Associated documents​

  • GP-001 Documents and records control
  • GP-012 Design, redesign and development
  • T-011-001 API key order
  • T-012-004 Version release
  • T-012-012 Customers product version control

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
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  • Purpose
  • Scope
  • Definitions
  • Responsibilities
    • JD-001
    • JD-005
    • JD-003
    • JD-004
  • Inputs
  • Outputs
  • Development
    • Product serial number and UDI assignment
    • Manufacturing date
    • UDI
    • EMDN code
    • GMDN code
    • Traceability
    • Productive state identification
  • Associated documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)