Quality Systems


Why implement a quality system?

Regulations for Medical Devices and In Vitro Diagnostics include quality system requirements. Although ISO certification is not a requirement, EN ISO13485:2016 is the harmonized standard for quality system requirements and ISO13485 certification will give the manufacturer structural advantages and improve business continuity.
  • 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.
  • The MDSAP audit program (USA, Canada, Brazil, Japan, Australia) is built upon the foundations of ISO 13485.


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 an audit-based gap analysis, 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.

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.

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.


Quality systems


« 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
« 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.

« 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. »




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