News

Journey to a new Frontier – The ISO13485 Revision Process, Future Implementation

It’s Ready for Publication! Finally, the long-awaited revision of ISO13485 is approved for publication   And as I travel around, met people and chatted about the possible impact to the medical device industry and specifically to any organisation’s quality management system, it became apparent that perhaps the process of standards development in ISO and the efforts …

Journey to a new Frontier – The ISO13485 Revision Process, Future Implementation Read More »

ISO13485 Revision Reaches The Final Stage

Revision development of the International Standard ISO13485 has reached the final stage, with the voting by the Participating (and Observing) members of the FDIS ongoing till the end of this calendar year (2015). On May 2015, I represented the ISO TC210 Workgroup 1 committee and presented some of the revision highlights in an Asia Pacific Medical Device Forum. They include: …

ISO13485 Revision Reaches The Final Stage Read More »

Of Hopes And Dreams

A newbie’s view of a healthcare entrepreneur’s gathering. I became part of the www.meetup.com community out of interest and joined one of the groups “Singapore Medical Technology Entrepreneurs” Well, the name of the meetup group sounds about right for me, and all this is for free, so, can’t go wrong, right?  :-)…..what’s next? I actually went to one event …

Of Hopes And Dreams Read More »

Setting the record straight…. what do some terms and phrases mean within the ISO13485 Standard

An opportunity came up to help provide clarity on some of the specifics within ISO13485 during a regional conference recently. These slides provide explanation to some of the terms and phrases within the Standard. Hope it helps the auditee and the auditor of any medical device company, or certification company, understand the ISO13485 Standard better. …

Setting the record straight…. what do some terms and phrases mean within the ISO13485 Standard Read More »