IVDR
Notified-body medical device certification for in-vitro diagnostic products according to regulatory requirements mandated by European and international norms.
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Medical Device Legislation
Tried-and-tested medical devices for global markets
As new technologies emerge in the healthcare industry, patient safety remains a number one priority. Organizations will need to hire new talent and/or work with organizations that have the right skill set for this dynamic, ever-changing industry. DEKRA provides you with the expertise for testing and certification services in the healthcare and medical devices industry.
The safety and quality of medical devices is becoming increasingly important as the healthcare industry prepares to enter the next decade. Firstly, consumers are demanding the highest safety standards from suppliers of products and services in the healthcare sector. Secondly, international rules and regulations for medical device manufacturers are becoming increasingly complex and stringent as devices become more innovative, but also more prone to privacy issues, security threats, and health risks.
We apply high standards, especially to ourselves
The DEKRA Certification B.V. top management declares the following commitment to impartiality: Our guiding principle is to fulfill and actively live the values which we look for at our customers. Only thus can we perform credibly as a service provider and role model with a customer-oriented approach. The basis for this is provided by our own management system and highest transparency internally and externally.
With the decisions they take in their daily activity, all the employees of DEKRA, including the Management Board, executives and staff, follow the principles of impartiality, objectivity and integrity.
- Bram Holtus, Managing Director
Medical Device Regulation (MDR)
Regulatory certification for medical devices subject to the strictest quality, reliability and safety compliance standards to protect public and private health.
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Medical Device Single Audit Program (MDSAP)
Program designed to efficiently provide medical device manufacturers a single audit report and certification recognized across several regulatory jurisdictions.
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UKCA Marking for Medical Devices
UKCA marking will replace CE-marking in Great Britain. DEKRA is in the process to become a UK Approved Body for medical certification.
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Meander 1051
6825 MJ Arnhem
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