Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the

Field Safety Notice (FSN)

A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action

CE Marking

CE certification verifies to regulators in Europe that medical devices meet all quality, safety and performance requirements of the applicable Medical Device Directives (including for In Vitro Diag

CE-marking technical file

A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clini

ISO 13485

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

Medical Device Software

A "medical device software”, refers to a computer application that meets the legal definition of a medical device and is not a part of any distinct product.

European Medicines Agency (EMA)

- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.

Adverse Drug Reaction (ADR)

Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.

Individual Case Safety Report (ICSR)

An Individual Case Study Report is an adverse event report for an individual patient.

Periodic Safety Update Report (PSUR)

The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.

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