Given the complex nature of the medical device industry, an effective QMS must be more technically driven and requires extensive documentation. ISO 13485 is the QMS standard that provides in vitro diagnostic and other medical device manufacturers with a framework to demonstrate that they consistently meet customer and regulatory requirements and are committed to quality and patient safety.
Based on the ISO 9000 series, ISO 13485 uses the process-based approach to ensure the quality of in vitro diagnostic and other medical device design, manufacturing, installation and service – for all stages of the product life cycle.
ISO 13485 is a minimum requirement for medical device manufacturers and at the core of numerous international market access programs, such as the Medical Device Single Audit Program (MDSAP), CE and UKCA marks.
We independently assess your QMS against ISO 13485 requirements and provide the certification required for market access.
We can help you to:
We can help you on your journey to ISO 13485 compliance, demonstrating that you meet the regulatory requirements for:
SGS Fimko’s certification services are accredited* by FINAS why you can rely on our professional assessment. Please familiarize yourself with Fimko’s accredited scope among system certification using FINAS web pages.
* SGS Fimko Oy is certification body no. S009 accredited by FINAS Finnish Accreditation Service, accreditation requirement SFS-EN ISO/IEC 17021-1:2015
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