New regulatory and legal changes require major adaptations in medical technology. Manufacturers are faced with increasing demands regarding quality, safety and effectiveness while at the same time they are under severe cost and time pressure. For that reason, Bertrandt as a service provider for medical technology manufacturers has further expanded its resources and range of services.
The new EU Medical Device Regulation (MDR) means that many medical devices will be classified in a higher risk class in the future, thus requiring an adaptation of the conformity assessment procedure. What is more, more products will fall under the scope of the Regulation. Products without a specific medical purpose, such as software applications, are now also affected. Medical products that have already been approved must be re-certified in accordance with the MDR. The need for action is therefore very great and the resources available to manufacturers are often limited.
Bertrandt has many years of experience in the field of medical technology and in complying with and implementing the regulatory and legal requirements. We have expanded our resources specifically to meet the requirements of the new EU Medical Device Regulation.