Quality Systems


 

Why implement a quality system?

Regulations for Medical Devices and In Vitro Diagnostics include quality system requirements.
  • The European Directives include quality system requirements. Although ISO certification is not a requirement, EN ISO13485:2012 is the harmonized standard for quality system requirements and ISO13485 certification will give the manufacturer several advantages.
  • In the USA, manufacturers are subject to QSR regulations (21 CFR 820 Quality System Requirements).
  • The Canadian authorities impose ISO13485 certification by a registrar, accredited by Health Canada.

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How can Qarad help with your quality system?

Whether your quality system still has to be built from scratch or only needs minor adjustments, Qarad can define what needs to be done to implement a quality system that is compliant with applicable regulations and/or quality system standards.
By gap analysis (audit), group training sessions, personal guidance, writing of documents, etc. we can give you the assistance that you need. We combine work in our office with on-site visits anywhere in the world.

Qarad also helps test laboratories with their Quality system implementation.
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Why is 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 20 years. We have personally dealt with the problems you may encounter with the implementation of a quality system for medical devices and in vitro diagnostics.

As consultants, we have successfully assisted IVD and MD manufacturers in achieving ISO13485 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.
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How to continue?

Contact us for more information. We would be happy to learn more about your situation and to make a proposal which suits your specific needs.

Also find out about our standard training packages and the possibility of outsourcing QA tasks.
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Quality systems
« AcroMetrix has definitely enjoyed the benefits of your knowledge and expertise with quality and regulatory issues in the EU community for several years. »
David E. Petrich
Life Tech AcroMetrix, Inc.

« 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. »

Dr. Meindert Niemeijer
IDx LLC