We’re excited to announce our latest online training
covering 510(k), PMA, De Novo Submissions, QMSR & FDA Compliance Pitfalls
This course is designed for regulatory, quality, and RA/QA professionals working with medical devices in the U.S. market — and those looking to stay ahead of regulatory shifts.
What you’ll learn:
- 510(k) and PMA submissions
- When (and how) to leverage the De Novo pathway
- How the FDA’s new QMSR aligns with ISO 13485 — and what’s still different
- FDA expectations for inspections, compliance, and CAPA
- Real-world examples of what NOT to say in a 483 response (yes, some are a bit wild…)
Whether you’re preparing your first De Novo or navigating QMSR implementation, this course gives you practical insights — not just theory.
Learn at your own pace, anytime, anywhere.
Check it out
Exclusive Offers for Students
Completion of our courses unlocks discounts and preferred rates on confinis services.
Other Courses on the Academy Include
Learn more and enroll today!
