CE MARK
Medra+ is specialised in providing CE Mark Consultancy Services by discussing with the clients and identifies the device scope for CE Marking along with Models, variants, and brands depends upon classification of product.
What Medra+ Does:
- We make aware of EN ISO 13485:2016 implementation to clients’ team members.
- Arranges Organization Structure along with duties and responsibilities.
- Helps in identifying the Notified Body and submitting the MDR/IVDR Application by assisting to do the following document preparation.
Technical
Risk Analysis
Declaration of Conformity
Biological Evaluation
Usability
Notified body
Clinical Evaluation
Post Market
- Identifies product-specific standards, harmonized and general standards applicable to the device with the support of the manufacturer.
- Collects information about materials, components, brought-out items, outsourced items, packing requirement specification along with BOM from Design & Development.
- Collects details about manufacturing process flow, environmental conditions.
- Collect details about device packing, labelling & transportation with the support of the manufacturer.
- Defines device description, intended, the indication of use, mechanism of action with the support of the manufacturer to prepare IFU.
- Supports in safety and performances requirement analysis and testing with the support of the manufacturer.
- Performs EN ISO 13485:2016 Internal GAP Assessment/IQA.
- Performs consolidation of technical documentation and internal review and correction.
- Conducts onsite QMS & Product Audit followed by the closing of all the findings with the support of the manufacturer.
- 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
- Supports in biological evaluation documentation and testing including validations and review reports
- Identifies the equivalent/similar device with same risk biological clinical and technical equivalency with the support of the manufacturer
- Identifies patient population, clinical conditions, contraindications, warnings with the support of the manufacturer to confirms statistical analysis
- Conducts Clinical Evaluation along with Post Market Surveillance and Periodic Safety Update Report
- Support IRB protocol/ follow up/ data monitoring and report writing
- Performs Risk Identification and Benefit-Risk Analysis with the support of the manufacturer.
- 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.
- Identifies and resolves risk analysis gaps including risk review report
- Performs Usability Engineering Documentation as per requirement
- Develop usability tests with client input to proceed documentation
- Supports manufacturer in setting up the PMS plan and PMS report/PSUR
- Supports manufacturer in carrying out the Post Market Clinical Follow-up (PMCF), sets PMCF plan and associated reports
- Identifies the conformity assessment route and draws a Declaration of Conformity.
- 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.
- Acts as an intermediary between the NB and the manufacturer by assisting in technical documentation submission and audit support
- Corrects NB review comments, modify/reply to NB with correction and supporting evidence
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