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Access-2-Healthcare partners with Industrial Technology Research Institute of Taiwan to help Taiwan medical technology organisations understand ISO13485:2016

What began as a friendly conversation between two blokes, led to a few more serious discussions and thus the training on the ISO13485 transition to the Taiwan medical device industry, jointly presented by Industrial Technology Research Institute (ITRI) and Access-2-Healthcare, on 7 July 2016, at the ITRI College in Taipei.

This training course is unique in the sense that it’s co-presented by two members of TC210 WG1 who had taken part in the development and writing of the current Standard (Albert Li and Ee Bin Liew), and that the training was entirely presented Mandarin Chinese.

Albert and I presented on the historical development of the quality systems and the ISO13485 Standard, as well as the makeup of TC210 and how Standards are revised, then proceeded to go clause by clause, in explaining the differences between the current Standard and the 2003 version as well as Taiwan GMP. Then the sessions went on to discuss the key actions in planning for the transition, and of course, questions and answers.




While it was mostly targeted for currently certified manufacturers, the training attracted a broad spectrum of attendees, from medical technology associations to startups to importers to design & development centres, and of course, manufacturers. It’s indicative that organisations understand that now the current Standard has extended its applicability to all organisations along the supply chain and the product lifecycle.



There were particular questions on software validation, application of risk, and the extent of design verification/validation, very similar questions to the training Access-2-Healthcare conducted to the New Zealand industry a couple of months ago. It’s proof that organisations typically have the same questions and concerns, regardless of geography, and culture.



It’s been more than a year since I had been in Taiwan. Coincidentally I saw a couple of friends whom I’ve not seen for some time in the training – that was good catching up. And one of my favorites – catching up with Taiwanese street food, as well as getting to know a pretty value-for-money sushi chain.

Although Typhoon Nepartak (m0re info) washed out the Tainan training the next day (with apologies to the participants who signed up there). we’re going to do this once again, in October 6th and 7th (Taipei and Tainan respectively). So for those who have missed out, here comes another opportunity!

I would like to say a big ‘thank you’ to ITRI – especially Albert Li, King Wang, and Tao-Ping Chen, whose hospitality, warmth and flexibility far exceeded anyone could have expected. The attention to detail in the organisation of the event, from start to finish, was top notch, and typical of the high standards that ITRI College have always carried themselves.


See all of you in October!

Chinese Version 中文版


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