Testing and approval of medical devices

FAQ

• Can FORCE Technology act as external Regulatory Affairs (R/A) partner?
  Yes, we can investigate the regulatory conditions for your specific product in specific markets. We call it" Approval Management", as there is more to it than just identifying requirements. It also comprises management of the approval as project manager, including own and third-party test laboratories, and assisting in the compilation of technical approval documentation, the so-called technical file or design history file. We aim to ensure that the labelling, attestation of conformity and all other parts of the documentation are performed correctly without flaws and deficiencies. 
• Does FORCE Technology make CB Scheme tests? 
  Yes, as a CB test lab (CBTL), we make CB-test reports and CB national certification body (NCB) test certificates. You can find our list of CB standards on IECEE's website.
• Does FORCE Technology offer approval guidance for medical devices? 
  Yes, our services include assistance with the intended use, use specification, classification, software, usability, risk management, national registrations and guidance on technical documentation. 
• Is FORCE Technology a notified body for the Medical Device Directive 93/42/EEC or the Medical Device Regulation (EU) 2017/745?
  No, we specialise in certain medical approvals but not in aspects such as clinical trials in collaboration with physicians. Our focus is on electromechanical and medical software, partnering with others for certification and consultancy.