ISO 13485 and CFR 820 Standard Operating Procedure Templates - SOPs
All templates and forms are in compliance with ISO 13485 ans CFR 820 FDA (USA) and EMEA (European) regulations. Using one of our standard operating procedure template (SOP template) will save you money and time due to quick and easy adaptation according to your need We provide high quality good manufacturing practice (gmp) documents and templates for the regulated health industry. Our main expertise is the Quality Management field for drug products, drug substances (active pharmaceutical ingredients, API), medical devices and the ISO regulated industry. Our Quality Management documents and standard operating procedure templates are built on the industry specific requirements and regulations. Conformance to ISO 13485 and CRF 820 of our documents is our first goal.
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Very well written Documents for Quality Management upgrades for our business. Compliance to 21 CFR 210&211 was of importance for us. We just had to make minor modifications to implement the procedures. Regards, Roy
- John Baxter - JB MD Consulting
I have purchased several SOP templates from QM-Docs to build up a QMS System for one of my costumers. The SOPs were very helpful and saved a lot of time for the implementation of the Medical Device QMS. Thanks a lot! John
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