We are a world-leading test house for hearing aids and the only Danish company doing certification of hearing clinics.
Technical audiological measurementsWe know how important it is for manufacturers that the audiological measurements are part of a complete approval process including EMC, safety, reliability, risk management, and all other parts of approval of medical equipment. Audiological tests of hearing aids as well as certification of more than 300 Danish hearing aid vendors require highly specialized knowledge. Thus, FORCE Technology's competences are requested by both the public sector, the hearing healthcare sector, the manufacturers, and universities.
For the hearing clinics it is essential that the certifying party has highly specialised personnel with practical experience with the manufacturers’ challenges.
Why choose FORCE for certification of clinics and test of hearing aids?To remain at the forefront of developments in the testing of technical audiological equipment, we are a member of several IEC/TC29 working groups involved in standardisation. We are involved in collaboration groups that are managed by the industry, and we share knowledge with the private and public sectors involved in hearing health care. We offer CB Scheme certified test reports according to IEC 60601-2-66 and will be pleased to manage all other aspects of the total approval of hearing aids as well.
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.
One-stop-shop for product compliance
As Denmark’s largest all-in-one test house, we offer to take care of the entire product approval process.
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