Certification and Standards

ISO 13485 Certification: Why It’s Essential for Medical Device Companies
20 Aug 2025 ISO 13485 Certification: Why It’s Essential for Medical Device Companies ISO 13485 isn’t just another standard — it’s the backbone of quality management for medical device c... Read More
CE Marking Process Explained: How to Get Certified in the EU
20 Aug 2025 CE Marking Process Explained: How to Get Certified in the EU For medical device companies, the CE mark is more than a label — it’s the key to entering the Europe... Read More
ISO 14971 and Risk Management: A Practical Guide for Manufacturers
20 Aug 2025 ISO 14971 and Risk Management: A Practical Guide for Manufacturers Risk management is at the heart of medical device safety. ISO 14971 provides the international frame... Read More

Explore certification pathways like ISO 13485 and CE marking. Practical guides and resources to meet international standards for medical devices.