Qarad BV of Geel at MEDICA 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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Qarad BV

Pas 257, 2440 Geel
Telephone +32 14 490422
Fax +32 14 582387

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This company is co-exhibitor of
Flanders Investment & Trade

Hall map

MEDICA 2021 hall map (Hall 3): stand G73

Fairground map

MEDICA 2021 fairground map: Hall 3

Our range of products

Product categories

  • 07  Medical services and publications
  • 07.10  Consulting services for health organisations

Our products

Product category: Consulting services for health organisations

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 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.

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Product category: Consulting services for health organisations

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.

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About us

Company portrait

Qarad is a consulting company, specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry.
Thanks to our wealth of experience in the field, Qarad is the ideal partner for all your RA/QA concerns:

  • CE-marking of your devices
  • Authorized Representative in the EU
  • Quality Management System implementation
  • Performance Studies for IVD
Our in-depth knowledge of IVD and MD regulations in combination with the strong belief that new technologies should make our customer’s life easier, also resulted in the development of our eIFU services. Our solution helps manufacturers to distribute their technical documentation via a digital platform. We differentiate ourselves in the eIFU field by offering a single supplier solution, developed by regulatory experts with a focus on compliance and risk management.