If you want to market a medical device or SaMD (Software as a Medical Device) in the United States, complying with FDA regulations (21 CFR Part 820) is mandatory. There is no way around it.

But here is what many companies discover the hard way: you don’t have to start from scratch. Implementing ISO 13485 is the globally recognized baseline that positions you for success and makes meeting FDA requirements significantly easier.

We’ve created a step-by-step roadmap to help you navigate both standards without the guesswork, costly mistakes, or unnecessary delays.

Inside this Practical Guide, you will learn:

• The 80/20 Rule of Compliance: How building your Quality Management System (QMS) on ISO 13485 satisfies the vast majority of FDA expectations.
• Supply Chain Clarity: Exactly who in your process (from developers to contract manufacturers) needs certification and who holds legal liability.
• SaMD Specifics: How to align software lifecycle and cybersecurity controls with regulatory expectations.
• A 10-Step Roadmap to Approval: From defining your scope and passing audits to building the perfect FDA submission (510(k), De Novo, or PMA).