Enquiry on Projects funded
under the SME Development Fund
Project Details
Project Reference :
D16003009
English Title :
To enhance the awareness and capability of local medical device industries in fulfilling the upcoming new requirements in newly-launched ISO13485:2016 Medical Device Quality Management System (QMS)
Chinese Title :
提升本地醫療儀器行業之認知及能力以對應新推出之ISO13485:2016醫療儀器品質管理系統之要求
Target Sector :
Medical and optical devices
Project Nature :
Process/product/technology development or improvement
Project Deliverables :
(i) One industry-wide enhancement scheme to assist SMEs in meeting the requirements of ISO13485:2016;
(ii) Four seminars to teach SMEs knowledge on ISO13485:2016 and its implementation;
(iii) Three workshops to offer hands-on experience on implementation of the requirements of ISO13485:2016;
(iv) A guidebook to summarise the requirements of ISO13485:2016, findings of the industry-wide enhancement scheme, recommendations on documentation upgrade and detailed approaches to enhance operation;
(v) A checklist for SMEs to self-evaluate and identify the gap between their current operation and ISO13485:2016;
(vi) A project website to disseminate the project deliverables; and
(vii) Helpdesk service to answer email and phone enquiries from medical device SMEs.
Project Duration (Months) :
23
Commencement Date :
15/05/2017 (dd/mm/yyyy)
Completion Date :
14/04/2019 (dd/mm/yyyy)
Grantee :
Hong Kong Medical and Healthcare Device Industries Association Limited
Collaborating Organisation(s) :
Hong Kong Trade Development Council
Hong Kong Critical Components Manufacturers Association Limited
Federation of Hong Kong Industries
British Standards Institution
SGS Hong Kong Limited
Implementation Agent(s) :
Hong Kong Productivity Council
Fund Approved :
HK$ 723,114