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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
- Branchen medical technology
- Fachaufgaben documentation, ISO 62304, quality management, Requirements Engineering
- DV-Aufgaben IT consulting
- Systemumgebungen organizational consulting
- Vorgehensmodell customer standard
Project periodProjektzeitraum15.06.2018 - 03.08.2018
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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