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    MDR TECHNICAL FILE GAP ASSESSMENT

    We identify the GAPs and Guide appropriate measures

    What is DOC?

    Check new EU MDR /IVDR Declaration of Conformity Contents

    CE Marking Consultants

    We are CE marking consultants and have operations in Germany, (United Kingdom), United States and Vietnam. Our headquarter located in Bangalore, India. In 1999, we began providing services to medical device makers. Our loyal current clients consider our team members to be their team for medical device regulatory compliance throughout the year.

    According to the “Perga,” we are the best and most well-established CE mark Consultants in the Asia Pacific and the Middle East. Barriers in MDR and IVDR CE Marking must be removed as soon as possible for both existing certificate holders and future applicants. For CE Certification, you can reach out to us directly.

    CE Marking Consultants

    Scope of CE Marking Consultants

    General

    1 – Discusses with the clients and identifies the Device Scope for CE Marking along with Models, Variants, and Brands.

     

    2 – Discusses and makes aware of EN ISO 13485:2016 Implementation to clients’ team members.

     

    3 – Arranges Organization Structure along with Duties and Responsibilities.

     

    4 – Helps in identifying the Notified Body and submitting the MDR/IVDR Application.

    Technical

    1 – Identifies product-specific standards, harmonized and general standards applicable to the device with the support of the manufacturer.

     

    2  – Gathers information about materials, components, brought-out items, outsourced items, packing requirement specifications along with BOM from Design & Development.

     

    3 – Gathers details about manufacturing process flow, environmental conditions.

     

    4 – Gathers details about device packing, labelling & transportation with the support of the manufacturer.

     

    5 – Defines device description, intended, the indication of use, mechanism of action with the support of the manufacturer.

     

    6 – Supports safety and performances requirement analysis and testing with the support of the manufacturer.

     

    7 – Performs EN ISO 13485:2016 Internal GAP Assessment/IQA.

     

    8 – Performs consolidation of technical documentation and internal review and correction.

     

    9 -Conducts onsite QMS & Product Audit followed by the closing of all the findings with the support of the manufacturer.

    Biological Evaluation

    1 – Identifies sources (Internal/External) for the Evaluation of Safety, Biocompatibility Testing, Physical characterization tests, Chemical characterization tests, Stability studies, Validations, Verifications, etc. with the support of the manufacturer

     

    2 – Supports in biological evaluation documentation and testing

    Clinical Evaluation

    1. Identifies the equivalent/similar device with the same risk biological clinical and technical equivalency with the support of the manufacturer
    2. Conducts detailed assessment about a similar generation(s) of the device available on the European Union or on international markets as given by the manufacturer
    3. Identifies patient population, clinical conditions, contraindications, warnings with the support of the manufacturer
    4. Conducts Clinical Evaluation along with Post Market Surveillance and Periodic Safety Update Report

    Benefit-Risk Analysis

    1. Performs Risk Identification and Benefit-Risk Analysis with the support of the manufacturer
    2. Sets up Risk Management documents such as Risk Management Plan (RMP), Hazard Traceability Matrix (HTM), Risk Management File (RMF), etc. with the support of the manufacturer
    3. Identifies and resolves risk analysis gaps

    Usability Engineering

    1. Performs Usability Engineering Documentation

    Post Market Clinical Follow-up

    1. Supports manufacturer in setting up the PMS plan and PMS report/PSUR
    2. Supports manufacturer in carrying out the Post Market Clinical Follow-up (PMCF), sets PMCF plan and associated reports

    Declaration of Conformity

    1. Identifies the conformity assessment route and draws a Declaration of Conformity.
    2. Confirms with the manufacturer regarding the details to be added in the DOC such as UDI-DI number, harmonized and non-harmonized standards, common specifications etc.

    Notified Body

    1. Work as intermediate between the NB and the manufacturer – technical documentation submission and audit support
    2. Corrects NB review comments, modify/reply to NB with correction and supporting evidences

    EU 2017/745 - MDR Consulting

    Our CE marking Consultants help the medical device manufacturers in commercializing their products in the EU market. As it is the transition time from MDD to MDR, we can help you identify what is missing from your technical file and what needs to be added.

     

    By now, you might have come to know what changes have been implemented in the MDR compared to the MDD, and if not, don’t worry! The CE certification consultants can guide you in the right direction to place your medical device in the EU market.

     

    Here are a few points you should take care of while transitioning to MDR and where we – the MDR CE marking consultants can be of your support:

    • Compliance to General Safety and Performance Requirements
    • Implementation of Unique Device Identifier (UDI) to keep a track of your devices
    • Strong and in-depth clinical data to prove safety and performance claims
    • Stricter equivalency measures
    • New classification rules and addition of re-usable surgical devices requiring NB oversight
    • Reporting of incidents in the EU portal – EUDAMED

    EU 2017/746 - IVDR CE Certification Services

    With the introduction of IVDR, it has become clear that bringing IVD devices to the EU market has become a nightmare. We can assist you in determining what is missing from your technical file and what has to be updated, as this is the transition period from IVDD to IVDR.

     

    Here are the major modifications to be aware of when submitting your IVD device to the EU market, as well as the areas where we, the IVDR CE marking consultants, can assist you:

    • Risk classes – moved from the list-based approach to a risk-based approach. Four risk categories A, B, C & D.
    • Conformity assessment routes were amended – to reflect new classification rules.
    • Performance Evaluation – required throughout the lifetime of the device, must be performed as per the Performance Evaluation Plan.
    • Requires providing clinical evidence reports on scientific validity, analytical performance, and clinical performance.
    • Post Market activities – Post-market Performance Report (PMPF) is a new requirement, PMS plan, PMS report, and Incident report and trending.
    • For scrutiny and traceability demands, Summary of Safety and Performance for classes C& D and the need for a Unique Device Identifier (UDI).