CE MARKING
You have questions. wE have answers.
It is a mark placed on some types of goods, and this mark has two very different meanings. You can be sure of the product as there is also a manufacture in the mother country. There is a company in France and in Holland. The CE mark was developed by the European Community in the 1980s and is an acronym for the European Commission or the European Community, from which the idea of the European Common Market was born.
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
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
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
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
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
1- Performs Usability Engineering Documentation
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
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
EN 
TR