Skip content
resource header

ISO 13485:2016 FAQs

Get the expert view on ISO 13485

+61 37 004 3410

Contact us

 

ISO 13485:2016 sets out the requirements for a quality management system (QMS) specific to the medical devices industry. 

LRQA's medical device technical experts answer some frequently asked questions on ISO 13485:2016, its relationship with other international standards, risk management, outsourcing and the support available for organisations going for certification.

Submit your details and we will email you a link to your PDF. You can also subscribe to our mailing list and receive content like this directly to your inbox.