Medical Device Manufacturers
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Healthcare and Medical Technology
Independent expertise for safe healthcare and reliable medical technology
The healthcare and medical technology sector is developing rapidly. Digitalization, connected medical equipment, increasingly stringent regulation, and continuous innovation are changing the way healthcare is delivered and medical devices are developed, manufactured, and used. At the same time, safety, quality, and reliability remain essential for patients, healthcare professionals, and organizations.
In the Netherlands, DEKRA supports healthcare organizations, manufacturers, developers, and suppliers of medical technology with independent certification, assessment, and testing services. Our expertise includes quality management, certification and conformity assessment of medical devices, product safety, and cybersecurity.
As an independent testing and certification organization, DEKRA helps organizations manage risks, comply with relevant standards and regulations, and demonstrate that processes, products, and systems meet applicable requirements.
DEKRA expertise for healthcare and medical technology
- Safety and qualitySafety and quality are fundamental in healthcare and medical technology. DEKRA independently assesses organizations, processes, and products, helping them demonstrate that relevant quality and safety requirements are effectively managed.
- Regulation and market accessMedical devices are subject to extensive European and international requirements. DEKRA Certification B.V. is a Dutch Notified Body for the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). DEKRA supports manufacturers with conformity assessment and certification activities that may be required to place medical devices on the European market.
- Quality managementA well-designed quality management system helps organizations manage and carry out their processes consistently. DEKRA provides certification in accordance with, among others, the Dutch HKZ standards, the European standard NEN-EN 15224 and the international standard ISO 13485.
- Technical expertiseMedical equipment increasingly incorporates electronics, software, and wireless connectivity. DEKRA has expertise in areas including electrical safety, EMC, usability, and cybersecurity to support manufacturers and developers in assessing the safety and performance of medical technology.