Download the checklist and fast-track your SaMD’s path to market.
This free checklist distills the latest FDA guidance, premarket cybersecurity expectations, and industry best practices into a practical, step-by-step guide designed for fast-moving startups.
Whether you’re preparing your first 510(k) submission or tightening controls post-market, this checklist will help you ensure your product is secure and compliant — from initial design through launch.
- Covers updated 2023 FDA cybersecurity guidance
- Tailored for resource-constrained startup team
- Aligns with IEC 81001-5-1 and FDA premarket expectations
- Actionable, prioritized steps you can implement today
