Product approval of medical devices
Get help with approval of your medical devices – legal requirements apply from the beginning of the development phase.
As a manufacturer of medical devices, you are met with many requirements and comprehensive regulationIt is a determining factor that you begin the process correctly and consider legal requirements for product and quality management, from the beginning of the development phase. To be able to meet the different test standards within EN 60601 or IEC 60601 family, you must be able to document product development according to standardized risk management in accordance with ISO 14971. Moreover, a number of supplementary tests are required: software, usability, mechanical and climatic, and of course EMC and safety.
Why let FORCE Technology be in charge of the approval of medical devices?We have many years of experience in testing and approval of medical devices, and we can guide you through the entire process. We are specialized in testing of medical devices within technical disciplines such as medico-EMC, safety, and reliability, including the required risk management system. Further, we are experienced in working in the cross field between medical devices and wireless devices, thus obtaining maximum synergy between the two worlds with considerable cost and time savings as a positive result.
We will be pleased to include new specific standards in our scope on request, enabling us to deliver accredited and CB Scheme certified as usual.
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.
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