Implement a Quality System
Regulations for In Vitro Diagnostics and Medical Devices include quality system requirements. Although ISO certification is not a requirement, EN ISO 13485:2016 is the harmonized standard for quality system requirements and ISO 13485 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 ISO 13485 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.
Let us help you
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.
We can give you the assistance that you need:
- We perform audit-based gap analyses.
- We organize group training sessions.
- We provide personal guidance.
- We write documents, such as procedures and processes.
By combining work in our office with on-site visits anywhere in the world, we can give you the personal approach that you need.