The Qarad regulatory and quality service offering ranges from high level strategic advice to hands-on support. It includes in depth training, consulting, technical file review or compilation and performance studies. Qarad also functions as the designated Authorized Representative (AR) for a vast array of IVD/MD companies around the globe, that do not have a registered place of business in Europe, including for manufacturers of highly regulated assays.

Qarad’s consultants have more than 25 years of experience in the IVD/MD industry, in Regulatory Affairs and Quality Assurance functions 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 also provides specialized electronic IFU (eIFU) services to comply with manufacturers’ regulatory needs, making available and maintaining Instructions For Use in an electronic format. This customizable service is used by a wide range of companies, from micro enterprises to large multinationals, allowing them to provide electronic instructions for use in a compliant way.

Consultancy in regulatory affairs

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 25 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, Performance Studies for IVD.


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 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. 


eIFU services

Because of the language requirements, the package inserts of IVD and Medical Device products often are very thick, hard to read and cause high printing and shipping costs. Qarad’s eIFU Services 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.



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