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Document clean-up for re-certification of a device for determining the Apgar score
Project duration: 1 year, 3 months
Brief description
The customer is attempting to renew product approval (EU and USA) for a timer that helps determine the Apgar score for newborns in the first few minutes after birth. 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. 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.
Subject description
The Apgar score is a scale used to assess the clinical state of newborns in a standardized manner. This assessment is used to describe the condition of the newborn and its adaptation to life outside the womb. (s. https://en.wikipedia.org/wiki/Apgar_score)
Overview
- Industries medical technology
- Specialist tasks Compliance, documentation, Requirements Engineering, test coordination, test evaluation, test management
- DV tasks IT consulting
- System environment technical data processing
- Procedure model V-Modell
Project period01.01.2017 - 31.03.2018
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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