Consulting: Quality Management
When it comes to harmonized standards for quality management systems, DIN EN ISO 13485 is the most commonly one used by medical device manufacturers. This standard remains suitable whether for companies specialized in the field of custom-made production and departments focusing on in-house production or service provider in the field of medical technology.
MDSS Consultancy offers proficient support for the installation, documentation and maintenance of a well working system. Our goal is to establish an effective system which is being used in your daily work.
Additional requirements such as DIN EN ISO 9001 (DIN EN ISO 14001), USA/FDA, requirements on quality management systems, Canadian requirements, risk management etc. will be integrated on request.
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