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Glossary

ISO 13485

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ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and is the most commonly chosen path for companies to meet QMS requirements in major international markets (i.e. Europe, Canada, Japan, Australia etc.). This standard covers areas such as design control, manufacturing processes, corrective/preventive actions, vigilance, Post-Marketing Surveillance PMS and more.

Other glossary definitions

I

International Birth Date (IBD)

The date of the first marketing authorization for any product containing the active substance granted…

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P

Pharmaceutical Establishment License (PEL)

Whilst marketing approval is granted for a given product, the company applying for marketing license…

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