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. 
• Can FORCE Technology perform CB Scheme tests?

  Yes, as a CB testing laboratory, we provide CB-certified reports for a wide range of standards relevant to technical audiological products. We use FORCE Certification A/S as an impartial subcontractor for product certification.

  See our list of standards on the 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 focus on electromechanical testing and medical software but collaborate with partners for certification and consultancy.