Guides and Resources

Staying compliant in the medical device industry can feel overwhelming. That’s why we’ve created the ultimate compliance checklist — a practical tool to help manufacturers, importers, and distributors stay on track with MDR, ISO 13485, and CE requirements.

For medical device startups, entering the European market starts with one major milestone: CE certification. While the process may seem intimidating, breaking it into clear steps makes it achievable — even for small teams with limited resources.

Under MDR, technical documentation is the backbone of compliance. Without it, no medical device can be certified for the EU market. This guide explains how to prepare complete, audit-ready documentation that meets regulatory requirements.

Audits can be stressful for medical device companies — but only if you’re unprepared. Knowing what questions auditors typically ask can turn an inspection into an opportunity to prove compliance and quality.

For medical device companies, ISO 13485 is the foundation of compliance and quality. But how do you actually implement it? This beginner’s guide breaks down the process into clear, manageable steps.

Under MDR, a Post-Market Surveillance (PMS) plan is not optional — it’s mandatory. This guide explains how to design a PMS plan that meets EU requirements and ensures your devices remain safe and effective throughout their lifecycle.