Freyr provides end-to-end services starting from device classification to market approval which includes appointing legal representative and guiding you in getting the certification like QMS etc. Our consultants are located worldwide so regardless of where you are located, we can assist you with regulatory issues offer a path to approval across multiple jurisdictions. We customize the process with respect to technical, service oriented and software assistance for the approval of medical devices according to the company size and ensuring high quality output.
Medical Device Registration - Specific Geographic Markets
Freyr has gained market approval for hundreds of medical devices of varied market clusters like US FDA, EMEA, GCC and APAC.
Freyr guides you in registering the device based on the below required approval procedures for US FDA Region.
- Premarket notification 510(k)
- Premarket approval (PMA)
- De novo petition
- Establishment registration and device listing
Freyr aids in making the approval process easier in European Union and is adept in tackling the multi lingual and complex regulations of different agencies.
- CE Approval
- ISO QMS Certification
- Appointing Authorised Representative
Freyr can accelerate the device approval by getting the licences to market in Canada .
- Medical Device Establishment license (MDEL)
- Medical Device license (MDL)
Medical Device Registration: Emerging countries (APAC)
Device registration process in emerging countries like APAC is a bit complex, read more about the processes for below listed countries.