Navigating the regulatory landscape – a notified body perspective.
June 30 @ 2:00 pm - 3:30 pm
From a Notified Body’s viewpoint, the fastest route to approval for orthopaedic start‑ups is disciplined preparation, transparent evidence, and early alignment with regulatory expectations. This webinar will be delivered by Kiwa (a world leader in testing, inspection and certification), who will explain how certification bodies/notified bodies evaluate orthopaedic devices and how start‑ups can avoid the pitfalls that delay conformity assessment.
The webinar will feature a case study from Iestyn Foster, Co-Founder & CEO of Amotio (an early-stage MSK business, part-funded by ORUK) on how his company is navigating the regulatory landscape.
The agenda will cover:
- How Notified Bodies View Orthopaedic Innovation
- Classification: The First Decision We Check
- What We Expect in Early Regulatory Strategy
- What a Notified Body Looks for in your QMS
- Evidence Requirements Through Our Lens
- Working Effectively With Your Notified Body
- Post‑Market Surveillance: A Critical Part of Certification
- Certification as a Strategic Advantage
