Quality Assurance
Qarad can build your entire Quality Management System or make minor adjustments to improve.

We can assist with:

  • ISO 13485
  • ISO 9001
  • 21 CFR 280
  • MDSAP audits

Qarad, a valuable partner

Qarad's consultants have held positions in the industry in Quality Assurance, Quality Control, Regulatory Affairs and product development for more than 30 years. We have personally dealt with the problems you may encounter with the implementation of a quality system for In Vitro Diagnostics and Medical Devices.

As consultants, we have successfully assisted IVD and MD manufacturers in achieving ISO 13485 certification and CE certification. Company sizes varied from 1 to 100 employees.

We are fluent in English, German, Dutch, French and Italian and have a passive knowledge (reading) of more languages. Therefore, we have been able to work with companies in more than 15 countries on four continents.

 

 
Contact us for more information
 


 

ISO 13485 / ISO 9001

The ISO 13485 standard is based on the general requirements of ISO 9001, but it is specifically designed for quality management systems for medical devices.

Qarad's experts can build the entire Quality Management System from scratch or we can perform gap analyses to improve your existing system.

« AcroMetrix has definitely enjoyed the benefits of your knowledge and expertise with quality and regulatory issues in the EU community for several years. »

Life Tech AcroMetrix, Inc.

21 CFR 820

Similar to ISO 13485 (the European standard for Quality Management Systems), manufacturers in the USA are subject to the 21 CFR 820 Quality System Requirements.

Qarad can assist in implementing a Quality Management System according to the 21 CFR 820 requirements.

« The auditor complimented us on the quality of our QMS documentation. Documentation that you helped us put together. Needless to say we are very happy about this, thank you for your help. »

IDx LLC

MDSAP audits

The Medical Device Single Audit Program (MDSAP) was developed to ensure that a single audit will provide efficient yet thorough coverage of the requirements of medical devices for all participating countries.

Qarad developed a tool to perform mock audits to verify whether you are ready for your MDSAP audit.

« Thanks to the help and preparation we have received from Qarad, we have been able to successfully pass the MDSAP certification audit without any non-conformities.»

Dr. Marijke De Roeve

Quality & Compliance Manager, Fujirebio Europe N.V

QARAD B.V.B.A.

ISO 13485 Certified

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