Automating FDA 510(k) Substantial Equivalence and ISO 13485 MedTech Compliance

Navigating FDA Premarket Notification (510k) Submissions

MedTech manufacturers face strict FDA regulatory scrutiny under 21 CFR Part 820 and ISO 13485 quality standards. Demonstrating substantial equivalence to a legally marketed predicate device is essential for Class II market clearance.

AI-Driven Substantial Equivalence Auditing

The FDA 510(k) MedTech Resolver ($999/mo) streamlines regulatory dossier compilation:

• Predicate K# Mapping: Side-by-side technical comparison of technological characteristics and intended use.
• ISO 14971 Risk Management: Automated hazard analysis and mitigation verification.
• Software as a Medical Device (SaMD): IEC 62304 lifecycle audit checks and cybersecurity guidance validation.