Medical device & combination product safety update (1)
Time & Location
About the event
Benchmark on FDA Combination Products / similar device update:
- Have we implemented the same solutions and controls?
Getting ready for the EU Medical Device Regulation (MDR):
- What needs to be ready for PV by May 2021 and beyond?
Manufacturer Incident Report (MIR) status from the markets:
- Who is requesting them?
- In which formats are they requested?
- How has the first year of reporting worked?
In terms of other markets:
- Japan requirements in April 2021
- What is the MHRA up to after Brexit?
The session will be facilitated by Martin Holm-Petersen, CEO at Insife