Free webinar - 5 Secrets for a successful 510(k) submission
12h - 12h30
This webinar is English spoken
In this webinar, MedTech innovators discover how FDA clearance can be transformed from a regulatory hurdle into a powerful accelerator for market success.
You can register here using MS Teams.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.
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
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.
Praktische informatie
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