Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on t...
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Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on t...
Having a document control system in place is a requirement of quality standards and regulations around the wor...
DHF, DMR, DHR… to the uninitiated they might sound like out-of-town furniture stores or airport codes for exot...
SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...
The regulations and literature surrounding medical device development are packed with acronyms and technical t...
Around the world different rules apply for the cultivation, manufacture and sale of cannabis and CBD products....
I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are i...
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%20(1).webp "ISO IEC 27001 (1) (1)")