![]() |
![]() |
|
![]() |
![]() |
|
Medical Device Regulations
Ombu offers training and consulting in medical device
regulations for manufacturers. We focus on three geographic areas of importance
to American manufacturers: US, EU, and In the In the EU the product directives (MDD, IVDD, and AIMD) govern and provide Essential Requirements supported by Harmonized Standards. In Overarching the regulatory system are the guidance documents from the International Medical Device Regulators form (IMDRF). |
||
![]() |
![]() |