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Quality Systems

Why implement a quality system?

  • Regulations for Medical Devices and In vitro Diagnostic Devices include quality system requirements.
  • The European MD and IVD Directives and MD and IVD Regulations include quality systems requirements. EN ISO13485:2012 is the harmonized standard for quality system requirements and ISO13485 certification provides a manufacturer several advantages.
  • In the USA, manufacturers are subject to the QSR regulations (21CFR 820 Quality System Requirements).

How can MARACA International help with your quality system?

Whether your quality system still has to be built or needs adjustments, MARACA International can guide you to what is needed for a quality system in compliance with the applicable regulations and standards.

This service can include a gap analysis audit, team training sessions, one-on-one guidance, writing of documents, development of templates, etc. or the outsourcing of Quality Assurance in full or partially.

MARACA International can provide this service from our office in Belgium or on-site any place in the world.

MARACA International also assists clinical laboratories with the implementation of their quality system per ISO 15189:2012 for Medical Laboratories, CLIA 42 CFR 493 Laboratory requirements or the FDA QSR 21 CFR 820.

More detailed information? We are happy to learn more about you and to make a proposal that suits your needs.