Certification of HypoCath
| Reference number | |
| Coordinator | MICROPOS MEDICAL AB (PUBL) - Micropos Medical AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | May 2019 - July 2019 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
Purpose and goal
The planned and degree of completion (2019-07-31) thereof: - Set-up the framework of the technical file- 100% completed - Coordinate the data provided from the different suppliers of the HypoCath with RayPilot specific electronically data - 85% completed - Set-up the biocompatibility documentation needed- 100% completed - Produce the technical file - 80% completed - Apply for review for CE-mark and support at the the review from the Notofied Body- 5% completed due to change of Notify Body
Expected results and effects
- Obtained planned and requested support for CE certification process - New relevant process incl know-how implemented in Micropos workflow - Additional development and quality improving steps implemented - Verified and gained trust in the decisions taken by the company - Competence transfered to QA/RA Manager and other persons at Micropos - All-in-all; significant improvements have been implemented in Micropos work process with the aim of the completion of the CE certification application to Notify Body.
Planned approach and implementation
Hired the consultant, Peter Löwendahl. Not many people in the Nordic countries have the breadth and depth that he gained by working at the multinational company GE Healthcare, medium size Elekta and startup companies such as Bioservo and for Intertek as a notified body. Has been responsible for> 40 FDA inspections and more than 150 other government inspections, responsible for developing or operating> 20 quality systems and> 3000 product applications over the past 25+ years. Implementation 100%