This IT project is part of our digitalization and optimization of our customers’ IT landscape. Through targeted measures, we promote technological progress, optimize cross-system processes and create a sustainable basis for future developments. Our IT reference projects serve as a basis for orientation. They support the reusability of tried and tested concepts as part of project implementation.
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Document clean-up for re-certification of a breast pump
Project duration: 5 months
Brief description
The customer is attempting to renew product approval (EU and USA) for an electrically operated breast pump. The existing documentation does not meet the current regulatory requirements in terms of structure, content and scope. As a consequence, all the quality-related and regulatory-related documents 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.
IT project data
- Industries medical technology
- Specialist tasks Compliance, documentation, Requirements Engineering, test coordination, test evaluation, test management
- DP tasks IT consulting
- System environments technical data processing
- Procedure model V-Modell
Project period01.03.2016 - 31.07.2016
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