DNV Product Assurance (DNV GL Presafe) - How to Apply for MDR Certification

The course gives you an understanding of the application requirements and the internal processes for application handling at DNV Product assurance. You will understand the details requirements for information needed. You will also learn how to avoid pitfalls and misunderstandings when applying for MDR certification, through advice, guidances and explanations

Course objective and outcome
The course gives you an understanding of the application requirements and the internal processes for application handling at DNV Product assurance. You will understand the details requirements for information needed. You will also learn how to avoid pitfalls and misunderstandings when applying for MDR certification, through advice, guidances and explanations.
 
Content
1. Intro
2. Certification process for MDR
3. Application process
4. Introduction to Single registration number, Basic UDI-DI, UDI-DI, UDI-PI
5. Introduction to coding of devices (MDA/N – device types, MDS - Specialities, MDT -Technology, EMDN/CND    device Nomenclature) used by Notified bodies
6. Review of the application form, including:
               - Scope of the application
               - Company information
                        - Details needed
                        - Subcontractors/suppliers and Multi Site organizations
               - Device information
7. Application review at DNV PA
               - Limitation of application review
8. Certification Agreement
9. Supporting documentation and guidances

The course comprises lectures and interactive workshops.
 
Who should attend?
- RA personnel and QA personnel involved in the application process
- Management responsible for MDR Certification
- Regulatory consultants
 
Trainer
Carsten Worm Jensen, Certification Manager MDR/MDD, DNV Product Assurance AS
 

Indtast et "Purchase order number" hvis din virksomhed forlanger det på fakturaen.

Kontakt

mp@medicoindustrien.dks billede
Morten Petersen
Uddannelseskonsulent
49184703