ISO 13485 Certification

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

Based on a process approach to quality management, ISO 13485:2016 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)base their medical device regulatory framework, in part, on ISO 13485. Manufacturers marketing medical products in those countries that recognize third-party audited and certified quality management systems will benefit from an ISO 13485-compliant system, and this certification might help expedite their market access.

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. The Medical Device Single Audit Program (MDSAP), a consolidated approach to medical device auditing, is slated to replace CMDCAS at the beginning of 2019. Despite this transition, the MDSAP scheme also intends to apply ISO 13485 requirements to ensure its effectiveness. Intertek’s years of expertise is built on extensive industry experience and partnership with regulatory authorities, allowing us to stay up to date on the latest requirements. We strive to consistently pass this wealth of knowledge on to you. 

When you select Intertek, you get much more than a certificate: you 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