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.
Scope of CE Marking Consultants
2 – Discusses and makes aware of EN ISO 13485:2016 Implementation to clients’ team members.
3 – Arranges Organization Structure along with duties and responsibilities.
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 file and documentation and internal review and correction.
9 -Conducts onsite Quality Management System & Product Audit followed by the closing of all the findings with the support of the manufacturer.
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 testing and documentation.
Identifies the equivalent/similar device with the same risk biological clinical and technical equivalency with the support of the manufacturer
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
Identifies patient population, clinical conditions, contraindications, warnings with the support of the manufacturer
Conducts Clinical Evaluation along with Post Market Surveillance and Periodic Safety Update Report
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
Performs Usability Engineering Documentation
Post Market Clinical Follow-up
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
Declaration of Conformity
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.
Work as intermediate between the NB and the manufacturer – technical documentation submission and audit support
Corrects NB review comments, modify/reply to NB with correction and supporting evidences
EU 2017/745 - MDR Consultants
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 marking 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 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 Marking Consultants
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).