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Documentation for re-certification of a breast pump
Project duration: 5 months
Brief description
The customer is attempting to renew product approval (EU) for an electrically operated breast pump. The existing documentation and records do not meet the current regulatory requirements in terms of structure, content and scope. As a consequence, all the quality-related and regulatory-related documents and records are compiled, coordinated, generated in audit-proof form, and then transferred to a customer-specific management environment.
Supplement
The company is globally active in the fields of medical vacuum technology and obstetrics.
Subject description
The task involves the fields of software, hardware and mechanics, and it covers the entire product development process, from documentation of the product idea, through to the acceptance test. The gaps in the existing requirements, specification, verification and validation documentation are identified and plugged as needed, in accordance with the proposed or agreed procedure.
Overview
- Branchen medical technology
- Fachaufgaben Compliance, documentation, FDA validation, Requirements Engineering, test coordination, test evaluation, test management, validation
- DV-Aufgaben IT consulting
- Systemumgebungen technical data processing
- Vorgehensmodell V-Modell
Project period01.05.2017 - 29.09.2017
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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