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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

U

Unanticipated death or unanticipated serious injury

A death or serious injury is considered unanticipated if the condition leading to the event was…

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M

Markov Model

Stochastic multi-state transition models. Transition between different states in the model are based upon pre-defined…

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