ISO 13485 Certification

Our medical industry expertise has brought confidence and assurance to thousands of organizations around the world.

Based on ISO 9001's process approach to quality management, ISO 13485:2003 focuses on what the manufacturer does to deliver safe and effective medical devices. Regulatory authorities in most major markets (including the European Union, United States, Canada, Japan, and Taiwan) require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality management system in place. An ISO 13485-compliant system expedites access into those countries that require it.

Intertek has extensive, global experience in the medical industry, both in management systems certification and in product safety testing and certification. We are fully accredited to offer third-party certification to the ISO 13485 standard, and are also qualified by Health Canada as a CMDCAS recognized registrar. Our staff members have many years of industry experience, and they work directly with regulatory authorities to stay updated on the latest requirements - resulting in a wealth of knowledge that we are able to pass on to you.

When you select Intertek, you'll get much more than a certificate: you'll get a knowledgeable business partner dedicated to helping you meet global requirements, avoid loss of production, and protect your brand.

Need help or have a question? +61 1300 046 837

Need help or have a question?

+61 1300 046 837
+44 (0) 116 296 1620
+1 800 810 1195
+46 8 750 03 33
Asia Pacific
+86 21 50273066