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Document clean-up for re-certification of a suction pump for the respiratory tract

Project duration: 6 months

Brief description

The customer is attempting to renew product approval (EU and USA) for an electrically operated suction pump for the respiratory tract. 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.

Overview

Project period01.06.2016 - 30.11.2016

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Ole Knudsen

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