GAP analysis and upgrade of quality management system for ISO 13485 compliance
|Funding from Vinnova||SEK 200 000|
|Project duration||March 2017 - June 2017|
|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.