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Documentation according IEC 62304 for a re-certification of a data interface for infusion pumps

Project duration: 2 months

Brief description

The customer is facing an audit by his notified body. The existing documentation for a data interface for infusion pumps does not meet the current regulatory requirements of IEC 62304:2015 with regard to structure, content or scope. Based on these nonconformities from a previous audit, PTA compiles the product documentation according to IEC 62304.

Supplement

In collaboration with the customer, PTA evaluates all quality and regulatory relevant documents and records of the product, and revises or creates them audit-proof.

Subject description

The main focus of the documentation to be revised is on stakeholder and product requirements, requirement traceability, software architecture, software specifications, risk management plan and risk assessment. Finally, an assessment according to IEC 62304 is performed and documented.

Overview

Project period15.06.2018 - 03.08.2018

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Ole Knudsen

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