Consultancy in quality assurance
Regulations for IVD and Medical Devices include quality system requirements, not only in Europe but also in the USA, Canada and other geographic areas.
Qarad’s consultants have successfully assisted IVD and Medical Device manufacturers in achieving ISO 13485 certification and CE certification in more than 15 countries on four continents. Depending on the situation, Qarad can build the quality system from scratch or only propose essential adjustments to an existing system. We can provide training, perform a quality system gap analysis, give ad hoc advice or manage your quality system on a permanent basis.
The consultants can help IVD and MD manufacturers in the implementation of a Quality System following standards ISO 9001, ISO 13485, CMDCAS and MDSAP.
For more information regarding our Quality Systems Services,
click here.