Our team of experts, led by Dominique Monferrer (Scientific & Regulatory Affairs Associate Director at Asphalion) regularly run courses on Medical Device and In Vitro Diagnostics Regulatory Affairs.
This month we have participated in:
- European Medical Device Regulations training session at IESE Business School – University of Navarra Center for Research in Healthcare Innovation Management on the 21st June 2018 to participants of the EIT Health #StarShip programme. The focus of the session was on understanding the key regulatory elements to consider in any new medical device development, from qualification viability, to requirements identification and demonstration of compliance.
- Training on the Regulation of Medical Devices organized by Fundación LEITAT on the 10th July 2018. A global view on the regulation for MDs and IVDs was provided, including the European legal framework, conformity assessment requriements and procedures, and development milestones for the CE marking of MDs and IVDs.
If you are interested we can prepare a personalized training according to your needs, or you can join open courses that we organize along the year (check our website).
We are specialists in MD&IVD regulatory affairs and can provide comprehensive support in Europe and the United States. Services include: Regulatory Roadmaps, Feasibility Assessments, Classification Strategy, Registration assistance, Compilation & Maintenance of Technical Documentation, Assessment in Country-specific Regulatory Requirements, etc.