Testing and approval of medical devices

FAQ

• Can FORCE Technology act as external regulatory affairs (R/A) partner?

  Yes, it is a core service at FORCE Technology to investigate the regulatory conditions for your specific product in designated markets. We call it "approval management" because it involves more than identifying requirements. It also includes managing the approval process as a project manager and assisting in compiling the approval documentation.

  It is essential for us to ensure that labelling, declarations of conformity and all other parts of the documentation are performed correctly without flaws.
  
  As a notified body, we know what we are talking about, and you can strengthen the validity of your documentation with a notified body certificate (see also the page Accredited product certification of electronic products).

• 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.