ISO 13485

Preparation. Certification.

The European Medical Device Directive (MDD) requires manufacturers of medical devices to implement a quality system. ISO 13485 provides the most commonly used method for meeting the quality system requirements in Europe, as well as in many other countries (e.g. Canada, Australia, Japan).

We have designed and implemented ISO 13485 compliant quality management systems for a wide range of medical device companies, with a broad spectrum of medical device types and manufacturing processes (e.g. implants, active medical devices, software, devices for ingesting, non-active devices, etc.)

Our services include:

  • Establishment and maintenance of a compliant quality system
  • Analysis of existing processes and documents
  • Identification of gaps in relation to ISO 13485
  • Documentation of the quality system and required SOPs
  • Training of employees
  • Preparation and support during Notified Body certification audits
  • Support in the implementation of these procedures

The Capamed Advantage:

  • Efficient and sustainable procedures
  • Efficient and competent preparation and support for ISO certification
  • ISO 13485 certification and MDD compliance