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ISO 13485 Certification

ISO 13485 …working with you to make better medical devices.

December 2019

We are delighted to announce that it’s official!

The quality management system we developed many years back to support our medical and scientific clients has been put through the rigours of European testing and come out trumps.

Tiller Design is now certified for Design and Development for Medical devices including related electrical, electronic, mechanical and software aspects as per EN ISO 13485:2016 by TÜV Rheinland – one of the oldest, most recognised certification bodies in the world.

“It has been a long process, but relatively simple, given that we already worked to the required standards; and with Europe’s new regulations becoming fully applicable for Medical Devices in May 2020, and May 2022 for IVDs, receipt of this full and final certification has been perfectly timed.

What has most surprised me comes from our recent research into the industry, where we discovered that while many product design companies have experience with medical devices, far less than we realised had full certification.

As we move into what we believe will be Australia’s MedTech Decade, we look forward to working with both our long-standing clients and many new companies – all of whom are driven to challenge and champion smarter ways.”

Robert Tiller

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