strengthening of regulatory/quality Medicvent

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.