Quick Contact
CE Marking Consultants
CE Marking Consultants provide manufacturers with the expert advice, documentation support, and guidance needed to navigate the medical device and in-vitro diagnostic device CE mark certification process successfully. cConsultants also ensure that their devices meet all requirements for market access in the European Economic Area.
We are CE Marking Consultants and have operations in India, Germany, the United Kingdom, and the United States. In 1999, we began providing services to device manufacturers. Our loyal customers consider our team members to be their team for medical device regulatory compliance throughout the year.
CE Mark Consultants Scope
Scope of CE Marking
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 Application / 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 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.
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 testing and documentation.
Clinical Evaluation
- 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
Benefit-Risk Analysis
- 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
Usability Engineering
- 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.
Notified Body
- 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
According to the “Perga,” we are the best and most well-established CE Marking 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. You can directly contact us for CE Marking Services.
EU 2017/745 - MDR Consultants
Our EU MDR 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 Mark 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 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).
How to build a Medical Device Technical Documentation as per MDR 2017/745? We have the answer and the right team to do it for you.
Frequently Asked Questions
Does I3CGLOBAL develop the technical documentation or just guide us?
The I3CGLOBAL team guides and develops the technical file for the manufacturer. We also take responsibility for the technical file revision and updations until CE marks approval from the Notified Body is granted.
How do you assure the data integrity and misuse of confidential information
We are IEC 27001 certified for data security. Our team comprises full-time technical consultants, and we do not outsource activities to third-party individual professionals. These in-house systems assure customer property.
Do you company provide turnkey service for CE marking?
Yes. the following services are covered in our scope.
- Documentation
- Testing (Biocompatibility and electrical)
- EU Representative
- Performance testing (a few types of devices)
- Transport Validation (Limited scope)
- Shelflife studies (Limited scope)
- Packing Validations (Limited scope)
- EUDAMED Registration
- Clinical Evaluation
- Risk Analysis
- Usability studies