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Quality System Implementation
In Vitro Diagnostics - Medical devices |
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Why implementing a quality system? |
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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, ISO13485:2003 is the harmonized standard for quality system requirements and ISO13485:2003 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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What can Qarad do to achieve your quality system? |
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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. |
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Why is Qarad a valuable partner? |
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Qarad consultants have held positions in the industry in Quality Assurance, Quality Control, Regulatory Affairs and product development for more than 15 years. We have personally dealt with the problems you may encounter with the implementation of a quality system. See “About Qarad” for more details.
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, French and Dutch, and have a passive knowledge (reading) of more languages. Therefore, we have been able to work with companies in more than 15 countries on 4 continents. |
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How to continue? |
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Contact us for more information. We would be happy to learn about your situation and to make a proposal which suits your needs.
Also find out about our standard training packages and the possibility of outsourcing QA tasks. |
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