Experience + Mission
For more than two decades the capabilities of Australian companies to produce orthopaedic devices in their own right has diminished, having been outsourced to international suppliers to a point where a serious lack of local expertise and know-how exists
At the same time international regulatory and compliance requirements continue to become more demanding.
Now multinationals and overseas suppliers dominate the Australian device industry despite a wealth of talented and enthusiastic entrepreneurs, clinicians and designers wishing to compete independently.
Device Synergies was founded to help reverse this trend.
We have the Experience, and Mission to help build local capabilities and Jobs.
Why Device Synergies?
Capabilities - Internal
CNC Drill Bit and Pin Grinding
CNC turning and milling
ISO 13485 2016 Certification Coming Soon
We want to help the Australian Medical Device Industry.
Do you want to start your own medical device manufacturing company or move your existing operations and QMS to the cloud?
Incorporating decades of experience in Australia, which is one of the most competitive and heavily regulated markets in the world, Device Synergies; with its broad industry network is in a unique position to do just that.
A Quality Management System should include total control over the manufacturing process, seamless links between Design & Development and Risk Management and full traceability from inputs to outputs and beyond into post market surveillance feedback.
Ensure ISO 13485 and ISO 14971 compliance requirements are clearly met, implemented and integrated across all phases of product life-cycle.
Let us show you how to build your own capability including a cloud based Quality Management System
Or, if it works for you - integrate with our system and get moving.
QA and Reg Consulting
Contract Product Development
START with a clear view of the Risks, so you don't end up with the "unforeseen" consequences of a poorly executed project.
Let us show you a comprehensive yet straightforward set of Product Development Strategies and Tools with fully integrated Risk Management per the requirements of ISO 13485:2016 and ISO 14971:2019
Device Synergies was founded by Managing Director Ewen Laird with 30 years experience in the Australian device industry.
Designer and Inventor, with a long list of executive and production positions in some of the biggest and most successful orthopaedic manufacturing companies in Australia including Director of R and D - Austofix Surgical; Director of Engineering - Global Orthopaedics and; Owner/Director of VIMEK P/L, the first full turn key implant manufacturing company in Australia, Ewen has played a pivotal role in many development projects from concept through to the operating theatre: Class I to Class III.
After building a strong network of connected, knowledgeable and trustworthy associates, Device Synergies, is in a very unique position to help and guide you.
We have assembled a group of talented individuals and suppliers combining many decades of experience covering competencies in Design and Development, QA and Regulatory Affairs, Manufacturing know-how, International Sales, and Systems Implementation.