Healthcare

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.

DEKRA tests and certifies the healthcare and medical devices industry

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.