ISO 13485

ISO 13485 – the internationally recognized standard for quality management in the medical devices industry – has a lot in common with the requirements of the medical directives AIMDD, MDD and IVDD. DEKRA has transformed ISO 13485 certification into an opportunity for you to improve your company’s efficiency and thus increase profits. What’s more, as many countries require this certification, it can open up new markets around the world.
We can help you comply with ISO 13485. We align our audit plan with your business goals and thus help you achieve your management objectives. When your facility is due for a quality system audit, the ISO 13485 enables you to combine the quality system requirements with the regulatory requirements. The DEKRA Notified Body auditor, who is also your contact for the medical directives (AIMDD, MDD & IVDD) CE certification, will be the lead auditor.
There are a number of good reasons for choosing DEKRA:
  • We are a recognized registrar for the Canadian Medical Devices Conformity Assessment System (CMDCAS)
  • All regulatory auditing for medical devices can be provided by a single company: we can certify your Quality Management System along with product-related aspects in a combined audit
  • Thanks to our CE auditing role we know your organization, quality system, and products
  • CE and ISO 13485 auditing are integrated, saving audit time (and money)
  • The regulatory knowledge of the Notified Body auditors is a distinct advantage during ISO 13485 certification
  • You have the assurance that your certificate has been issued by one of the leading Notified Bodies in the world