ISO 13485 & FDA Compliance Roadmap for Medical Device Development

Achieve 1st-time audit pass with proven strategies while reducing delays and rework.

About This Guide

Bringing a medical device to market takes more than innovation. It takes compliance that stands up to FDA and ISO requirements. Too often, companies burn months and millions fixing mistakes they could have prevented. This guide gives you the roadmap to avoid those pitfalls and get to market faster.

What’s Inside

• Why DIY compliance fails and what it really costs
• Step-by-step roadmap to ISO 13485 & FDA compliance
• Pro Tips & FYIs to stay audit-ready at every stage

Who This Guide Helps

✔ Class II & III medical device manufacturers
✔ Teams struggling with FDA/MDR/ISO 13485 compliance
✔ Companies aiming to avoid delays, failed audits, and costly rework
✔ Firms building connected devices (SaMD, firmware, RPM) needing compliance-ready systems