Regulatory Strategy Call
Use this session to review where your documentation stands before it’s tested in a submission or audit.
We’ll look at what would be challenged if a Notified Body or regulator reviewed your file today, and where things may not hold up.
In this session, we typically:
Identify gaps in clinical evaluation, performance evaluation, or post-market surveillance strategy,
Flag issues in CER, PER or PMS/PMCF that are likely to be questioned,
Clarify classification, market scope and approval pathways,
Assess audit or Notified Body readiness risks based on what we’re seeing in current reviews, or
Set out the next steps to get things into a stronger position
This is designed for founders, regulatory leads, and clinical teams working on medical devices and IVDs who need a clear view of where they stand.
Your session will be led by Alastair Selby, Managing Consultant at SciMed Consultancy Ltd.
You’ll leave with a clearer understanding of what holds up, what doesn’t, and what to fix first.
If you’re not ready to schedule a call, you can submit a regulatory enquiry instead.