I am developing a new medical device. Do I always have to provide evidence of its medical benefits via a clinical evaluation? BEO BERLIN can take over responsibility for the clinical evaluation and clarify whether sufficient validation is available in the literature.
MDEL – Canada & Small Business Cost Reduction
Manufacturers holding a Medical Device Establishment Licence (MDEL) for Canada were contacted by Health Canada in December and the Annual Licence Review (ALR) Package was submitted with it.
