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strengthening of regulatory/quality Medicvent

Reference number
Coordinator Medicvent Aktiebolag - Medicvent Umeå
Funding from Vinnova SEK 200 000
Project duration September 2017 - February 2018
Status Completed
Venture Medtech4Health: Competence Enhancement in SME

Purpose and goal

Upgrades, regulatory and quality have been implemented and the company has been able to demonstrate that we are "compliant to standard", which enables us to survive as a company and can continue to develop. The staff has gained competence and, with little support, can continue with quality work and documentation, on their own.

Expected results and effects

The Quality system is upgraded to the new standard and documentation has been improved. The staff has acquired a higher competence from the appointed regulatory expertise.

Planned approach and implementation

We have, in close cooperation with the consultants, reviewed the upgraded requirements primarily 13485 and the requirements for improved documentation. We made an action plan that has been implemented. The actions have been implemented October - February, ongoing by internal staff and external expertise.

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 2017-03750

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