Medical Device Services

Ensuring safe medical devices for global markets

Medical Device Regulatory Services

Assessment and certification services for the healthcare and medical devices industries

As a medical device manufacturer, you must navigate your way through a complex landscape of regulatory requirements before you can sell your devices on the international market. International standards and European directives are there to ensure that products are safe and function accordingly.

Why DEKRA for Medical Device Regulatory Services

  • European Notified Body: We are one of the five largest Notified Bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostic medical devices
  • Recognized auditing organization for MDSAP: The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions. DEKRA is a recognized auditing organization for MDSAP
  • Globally recognized certification body: With a global network of offices and state-of-the-art laboratories, we can help you to gain worldwide access to markets including Europe, Taiwan, the USA, Canada, Brazil, Australia and Japan

How can we help you with Medical Device Regulatory Services?

It is essential that your Notified Body has the capabilities and expertise to support you with robust product certification and system certification reviews to ensure patient and user safety. We are active almost everywhere in the world and the members of our medical device team have extensive expertise in a wide array of medical and in vitro devices.

In addition to being a designated European Notified Body, we are also a recognized MDSAP auditing organization and CMDCAS Registrar. We offer all the essential services to manufacturers of medical devices: AIMDD (MDR), MDD (MDR), IVDD (IVDR) and MDSAP. Continue reading on more specific pages about Medical Device Regulatory services in case you are looking for more (technical) details or reach out to one of our experts for more information.

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