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GAP analysis and upgrade of quality management system for ISO 13485 compliance

Reference number
Coordinator BIOARCTIC AB
Funding from Vinnova SEK 200 000
Project duration March 2017 - June 2017
Status Completed
Venture Medtech4Health: Competence Enhancement in SME

Purpose and goal

The project goal to perform a GAP analysis and to upgrade the company´s quality management system to meet the regulatory requirements on current operations, and future ISO13485- certification has been reached.

Expected results and effects

The project was expected to support the company´s preparations, required for ISO13485 certification and subsequent CE-marking of its product for commercial launch. The quality managment system has been upgraded to meet regulatory requirements on existing operations, and to allow future ISO13485 certification.

Planned approach and implementation

The project plan with an initial GAP analysis, followed by the revision and upgrading of relevant processes and documents in the quality managment system, has been excecuted according to plan and the project objective was reached.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 25 November 2019

Reference number 2017-01719

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