Under the Industry Competence Assessment Scheme, the project team has reviewed the procedural documents and conduct on-site visits to companies and consolidated the findings into the Industry Guidebook. 

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Common weak areas of the participating companies have been highlighted in the Guidebook, while recommendations have also been given so to benefit other industry stakeholders. 

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With the help of this Industry Guidebook, the project team is hoping to minimize the gap between the local electronic SMEs operations and the requirements from medical device Quality Management System (QMS) in different regions, and also to give a step forward for their future certification/full compliance of medical device QMS. 

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