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© DEKRA CERTIFICATION B.V.
DEKRA provides you with 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.
Patient safety remains the number one priority. As new technologies emerge in the healthcare industry, organizations will need to hire new talent and/or work with organizations that have the right skill set for this dynamic, ever-changing industry.
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Innovations are transforming the healthcare industry, leading to new regulatory requirements for medical devices and other products and services.
Cybersecurity is becoming a real issue as healthcare devices become ever-more complex.
National, European, and global authorities are aiming to align and reconcile regulations and directives.
Ensuring the safety and quality of your products starts with DEKRA. 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. With a global network of offices and state-of-the-art laboratories, we help you to gain worldwide access to markets including Europe, Taiwan, the USA, Canada, Brazil, Australia, and Japan. In addition, we can provide you with certifications for your quality management system in combination with CE certification.
Connected medical devices
We also offer you a very comprehensive service portfolio for connected medical devices with amongst others services in testing for electrical safety, electro magnetic compatibility, interoperability, wireless, performance, usability, and cyber security.
Single point of contact
At DEKRA, we work to make your certification process as smart, fast, and safe as possible – by providing a single point of contact, by taking your specific requirements into account, and by assessing the quality and market value of your product. Our extensive network of experts in both the technological and the clinical field have many years of experience with high-risk medical devices and the stringent regulatory requirements.
We test and certify amongst others:
• Testing and certification of mobile and wearable medical devices
• Certification of in-vitro diagnostic medical devices
• Testing and certification of active medical devices
• Certification of quality management systems
Stay updated on the knowledge and solutions that help you be competitive in the healthcare market. Subscribe to receive relevant information from DEKRA about events, market trends, standards and regulations.
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
We rarely get as many questions about a topic as we do about the Medical Device Regulation (MDR). In our FAQ, you will find the answers to the questions we get time and again. Check it out frequently, because we will add more questions and answers to them from our experts.
Looking for a party that can help you navigate the challenging landscape of regulatory requirements in the medical devices market? Learn about our services amongst which are conformity assessments, evaluations, and certifications of products as well as management systems.
The MDSAP was designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions, such as Australia, Brazil, Japan, Canada, and the US. It aims to enlarge efficiency and safety through increased consistency. DEKRA performs MDSAP audits and keeps you up to date on the latest developments about the program.
Exploring global markets can be the key in achieving sustained growth. If exporting products is on your agenda, DEKRA can help you navigate international rules and requirements to obtain the local certification and approval marks that you need.