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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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The Hong Kong Electronic Industries Association (HKEIA) has cooperated with Hong Kong Productivity Council (HKPC) to implement a government funded project - "To enhance the ability and upgrade the local electronics industry for entering the smart medical and healthcare device industry focusing on parts and components market". The aim of the project is to enhance local electronics SMEs’ understanding on international regulation requirement of smart medical and healthcare devices.

One of the deliverables in this project is to organise a series of seminars for our local electronics manufacturers to strengthen their understanding on the latest compliance requirement of smart medical and healthcare device components. HKPC has invited specialists to present the findings of the Industry Competence Assessment Scheme and provide suggestions to local electronic SMEs to achieve ISO13485:2016 standard.

Speakers:

Mr Adrian Valea

Managing Director at ADVA Software Engineering GmbH
Former Project Manager in SiemensVDO

Former Senior Sales Manager in BTC Embedded Systems

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Mr Raymond Lin

Project Manager | Medical Greater China
TÜV Rheinland

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The Hong Kong Electronic Industries Association (HKEIA), has cooperated with Hong Kong Productivity Council (HKPC) to implement a government funded project - "To enhance the ability and upgrade the local electronics industry for entering the smart medical and healthcare device industry focusing on parts and components market". The aim of the project is to enhance local electronics SMEs’ understanding on international regulation requirement of smart medical and healthcare devices. One of the deliverables in this project is to organise a series of workshop for our local electronics manufacturers to strengthen their understanding on the latest compliance requirement of smart medical and healthcare device components. HKPC has invited specialists to present the findings of the Industry Competence Assessment Scheme and provide suggestions for local electronic SMEs to upgrade their QMS to ISO13485:2016 standard.

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HKEIA, collaborating with HKPC, has successfully organised a seminar to introduce the importance of traceability in electronic component manufacturing. Traceability is a new concept brought by ISO13485:2016. The enhancement of traceability in the manufacturing process can help in gaining clients from medical industries and reduce the risk of total recall. We are delighted to have Mr. Ee Bin LIEW, Member of the ISO/TC210 JWG1, to introduce the rationale and application on traceability management.

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Title: Good Traceability – to win your customer with value adding service in the medical device business

Speaker: Mr. Ee Bin LIEW,  Member of the ISO/TC210 JWG1

Content:

• Traceability – Why it is important for medical device producer to select firms with appropriate track-and-trace arrangement

• Traceability and Recall Handling – How to avoid a total recall by improving traceability

• Solution Application Sharing

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Seminar Program:

◇ Latest Technology and Trend on Electrical Sensors for Medical Use with Sharing on Design and Fabrication Consideration Prof. Paul R. Stoddart, Director, Swinburne University of Technology

◇Compliance Testing Requirements for Electronics Sensors for Medical Use Mr Terry Chan, Wireless Lab Manager, Intertek Hong Kong

◇Smart Healthcare and Medtech Case Sharing by HKPC Mr Bryan So, Principal Consultant, Head of Smart Healthcare, Medtech & Optics Unit, Automotive & Electronics Division, Hong Kong Productivity Council