Dr. Grömping Consulting
Practical Consultations and Support in QM & RA
Worldwide regulatory requirements for medical devices and in-vitro-diagnostics are growing. Especially the introduction of the EU medical device regulations (MDR and IVDR) is notable in this context. These constant growths and changes make it more and more difficult to penetrate the fog of the regulations and to bring medical devices to market. Sometimes it is even more challenging to make sure that the products do go on complying with global regulations.
I am looking forward to help you getting a clear view again and sailing around all dangerous cliffs: More than 25 years of experience with a European Notified Body, in quality management and regulatory affairs as well as in technical documentation and research & development show my hands-on knowledge. Thus, I always have an eye on the practical implementation and the long-term success of your company.
My Focus
- Market Access in the EU, US (510(k) and DeNovo), China, Canada + …
- MDR/IVDR Compliance (incl. adaptation of technical documentation)
- Quality Management incl. adaptation to ISO 13485:2016
- Risk Analysis acc. to 14971 as well as special standards
- Clinical Evaluation (MD) / Performance Evaluation (IVD) and Clinical Investigations
- UDI (Unique Device Identification)
- Usability acc. to IEC 62366
- Biocompatibility according to ISO 10993-1 to 20 + special standards
- Post Market Surveillance
- MDSAP (since Jan. 1, 2019 required for Canada)