Technical audiology - Audiological tests on hearing aids, certification of hearing clinics

FAQ

• Can FORCE Technology act as external Regulatory Affairs (R/A) partner?
  Yes, it is one of FORCE Technology’s key services to investigate the regulatory conditions for your specific product on specific markets. We call it ”Approval Management”, since 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 compilation of approval documentation, the so-called technical documentation or technical construction file. It is important for us to ensure that the labelling and the attestation of conformity as well as all other parts of the documentation basis are performed correctly without flaws and deficiencies.
  
  As notified body we know what we are talking about, and you have the possibility to strengthen the validity of the documentation with a notified body certificate (see Certification).
• Is FORCE notified body on Medical Device Directive 93/42/EEC or Medical Device Regulation (EU) 2017/745?
  No, FORCE has certain medical approvals as a key competence, but not elements such as clinical testing in cooperation with doctors. We concentrate on electromechanical and medical software and use partners for certification and consultancy. 
• Does FORCE Technology make CB Scheme tests?
  Yes, as CB testlab (CBTL) and CB national certification body (NCB) we make CB-certified reports. You can find our list of CB standards on IECEE’s website. 
  
  The list is continuously extended, also on request.
• Does FORCE Technology offer approval consultancy for medical devices?
  Yes, we combine internal top resources with the best medico consultancy companies in the business to be able to deliver all aspects of the approval at the same high level as our test reports and certificates.
  
  Our services include gap-analysis between MDD and MDR, assistance with description of intended use, classification, software, usability, home and healthcare, national registrations, clinical evaluations and guidance on technical documentation.