More than 30 years experience in IVD
The Qarad regulatory and quality service offering ranges from high level strategic advice to hands-on support.
Qarad’s consultants have more than 30 years of experience in Regulatory Affairs and Quality Assurance in the IVD and Medical Devices industry, giving them a wealth of experience. Through participation as a stakeholder to the European Commission’s IVD Technical Group, they are at the forefront of regulatory developments.
Qarad’s consultants assist manufacturers in their regulatory processes. They will clarify the numerous requirements in the European Directives and Regulations for in vitro diagnostics and medical devices, propose practical solutions to meet them and/or compose your technical documentation and design dossiers. Whether you only need training in the Directives and Regulations or you want to completely outsource your regulatory affairs activities, Qarad can provide a suitable solution. While doing this, we take your ambitions outside Europe into account.
With more than 30 years of experience, especially in the in vitro diagnostic industry, Qarad’s consultants are the perfect support for obtaining the required CE mark, through training, review/composition of technical documentation, assistance in notified body selection and much more. Qarad also acts as the European Authorized Representative (EC REP) for in vitro diagnostic and medical device manufacturers. Our company is the intermediate between the manufacturers and national authorities for a.o. incident management and product notification.
For more information regarding our Regulatory Affairs services, click here.
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.
Quality systems according to: