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Access-2-Healthcare Partners with Rob Jelas Regulatory Training & Assistance to Help New Zealand manufacturers Understand ISO13485:2016

“Since New Zealand gets the first rays of sunlight, why not be the first to receive the face-2-face training for the new ISO13485 from us?”

With the release of the ISO13485:2016 on March 1st, Access-2-Healthcare and Rob Jelas embarked on a journey to engage with the NZ medical device manufacturing industry in an aim to provide familiarisation and advice on the revised Standard for all of the currently certified medical device manufacturers in New Zealand.

Where is Christchurch?


Bottom Right Corner of the Earth


Literally, bottom right corner of the earth. Only the experienced are aware that around the South Island has a cluster of medical technology companies, around Canterbury, Timaru, Dunedin areas

The industry manufacturers attended a one-day seminar in Christchurch on 20 May 2016. The history of ISO13485’s revision, the structure and organisation of ISO and TC210, and all of the salient points related to the changes from the 2003 to the 2016 version of the Standard.


Arrived at Christchurch


Even just the carpark looks great!


“It’s unlikely that any country’s medical device industry other than New Zealand can have this level of closeness in engagement” – Ee Bin Liew

It was a unique opportunity to get together the local industry, as it doesn’t happen often. All the participants got to know one another, shared notes and problems, and perhaps created the start of a closer knit community amongst themselves. It’ll be difficult to replicate this unique intimacy and friendliness that the New Zealand medical device manufacturers have displayed. What was also interesting is the manufacturers from Wellington and Auckland also flew in to join us.



Participants in full concentration



Medsafe up close with the NZ manufacturers


Rob Jelas welcoming and presenting Chris James, Acting Group Manager, MedSafe, MInistry of Health


Chris James, Acting Group Manager for MedSafe, Ministry of Health, came along in the afternoon and shared the latest on the draft NZ Legislation (available for public viewing and comment), as well as the proposed regulatory framework to the NZ manufacturers.



Chris James explains the objectives of the new Legislations for Therapeutic Products in New Zealand


This gave a much-appreciated face-to-face contact between the local industry and MedSafe that’s bring everyone closer together, in enabling safe and effective medical devices being produced with an efficient and un-burdensome oversight by MedSafe.



The conclusion – and a sequel
The session concluded with a healthy discussion on some key topics such as risk, software validation, supplier controls and regulatory requirements, the transition timeline, and the upcoming two-day intensive course (clause by clause analysis, transition + action plan, audit prep) to help manufacturers transition efficiently and effectively. Yes, we’ll be back!


Christchurch Training’s Group Photo


Great to be home

Overcoming many challenges, including Ee Bin’s huskier-than-usual voice, the training went along just fine. The meeting venue was appropriate, and all was held in a friendly, relaxed and practical manner just as only kiwis would have it. Certainly made Ee Bin feel at home.



Rob Jelas in action


Thank you Rob!

I’d like to ‘shout out’ to Rob Jelas, whom I’ve grown to know as a fine gentleman, with a zippy and positive attitude to everything, and a sincere willingness to help everyone. He has been a pleasure to work with, especially in times to overcome obstacles together. More collaborations ahead!



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