What you get

Drawing on 20+ years of hands-on experience and 50+ successful 510(k) submissions, Mieke Janssen will reveal:

? Why FDA clearance is more than a legal obligation — it can strengthen your commercial strategy.

? The biggest mistakes startups and scale-ups make when preparing their submissions.

? 6 Eye-opening insights that shift how you look at the FDA process.

? 5 Clear steps to faster, more consistent clearance with fewer review rounds.

? Practical tools, including a reviewer checklist and a template to connect claims, risks, and evidence.

In addition to covering 510(k) submissions, Bart Leekens will briefly review the FDA QSR to QMSR transition, highlighting key differences and potential impacts on your quality system

Who is this webinar intended for?  
This webinar is specifically designed for start-up and scale-up medical device innovators that wish to break through in the American market (USA). It is also valuable for more established companies who want to extend their knowledge and confidence to successfully navigate the 510(k) process.

• CEOs, founders
• QA/RA Managers
• Commercial Managers
• Product Developers, R&D teams

Register for free and discover the secrets to a successful 510(k) submission.

Ready to put your plans into action after the webinar? Or do you still have questions?
Book a free consultation with Mieke. Together, you can take the first steps towards entering the American market.