Get help with approval of your medical devices – legal requirements apply from the beginning of the development phase.

As a manufacturer of medical devices, you are met with many requirements and comprehensive regulation

It is a determining factor that you begin the process correctly and consider legal requirements for product and quality management, from the beginning of the development phase. To be able to meet the different test standards within EN 60601 or IEC 60601 family, you must be able to document product development according to standardized risk management in accordance with ISO 14971. Moreover, a number of supplementary tests are required: software, usability, mechanical and climatic, and of course EMC and safety.

Why let FORCE Technology be in charge of the approval of medical devices?

We have many years of experience in testing and approval of medical devices, and we can guide you through the entire process. We are specialized in testing of medical devices within technical disciplines such as medico-EMC, safety, and reliability, including the required risk management system. Further, we are experienced in working in the cross field between medical devices and wireless devices, thus obtaining maximum synergy between the two worlds with considerable cost and time savings as a positive result.

We will be pleased to include new specific standards in our scope on request, enabling us to deliver accredited and CB Scheme certified as usual.