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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

F

Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to report any…

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S

Serious (Public) Health Threat

Any event type, which results in an imminent risk to the study population of death,…

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