Qarad's consultants assist manufacturers in their regulatory processes. They will clarify the numerous requirements in the European Directives 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 on the directives 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 20 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.
Other regulatory services: Risk Management, REACH/CLP, Performance evaluations for IVD.
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 MD manufacturers in achieving ISO13485 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 ISO9001, ISO13485, CMDCAS and 21CFR820. To Test Laboratories, assistance on ISO17025 and ISO15189 is available.
In many EU member states, the Instructions for Use of medical devices and IVDs have to be in the national language. Finding translators with the appropriate experience is not easy. Therefore, Qarad offers manufacturers a translation service for all their technical documents, such as the Instructions for Use.
Because of the language requirements, the package inserts of IVD products often are very thick, hard to read and cause high printing and shipping costs. Qarad’s E-Labeling service brings a solution: the Instructions for Use are made available to your customers through our user-friendly and secure website. The service includes a 24/7 multilingual freephone service and thus is fully compliant with European and FDA guidance.