|
Precise Global has partnered with Ellex to drive the commercial application of innovative medical technologies in Australia. As a combined entity with more than four decades of experience in product design, technology development and manufacturing, Ellex Precise specialises in the provision of a range of commercial and technical services focused in the medical arena.
Our shared experience in engineering design and development, precision machining and low-volume artisan manufacturing, combined with extensive expertise in regulatory approval and project management, will enable us to provide practical, hands-on support in order to help bring your technology to market.
Our capabilities include, but are not limited to:
- Engineering Design and Development
- Precision Machining
- Tooling and Manufacturing
- Project Management
- Regulatory Strategy and Approval
 Download our Overview Brochure
|
 |
About Ellex
Ellex Medical Lasers Ltd (Ellex) designs, manufactures and markets a comprehensive range of medical laser and ultrasound systems. With engineering and manufacturing based in Adelaide, Ellex has grown its business from original equipment manufacturing (OEM) for some of the largest companies in ophthalmology, to a market-driven company which manufactures and sells is own medical technology. Over the past 25 years Ellex has established direct sales subsidiaries in Japan, the United States, Europe and Australia, supported by a network of distributors in more than 100 other countries.
About Precise Global
Precise Global Pty Limited (Precise Global) specialises in technical development and supply chain management for both small- and large-scale projects in the medical, aerospace, defence, renewable energies, mining, automotive and consumer industries. Expert project management skills, combined with a strong technical capability and a global network of suppliers and industry partners, enable Precise Global to execute all facets of your manufacturing product commercialisation projects.
|
Ellex Precise offers a number of services to support the development and commercialisation of innovative medical technologies. These services can be utilised together as part of a comprehensive commercialisation program, or individually as your needs require. Our aim is to help make your concept a commercial reality. 
| | 1. Product Engineering Design and Development
Ellex Precise’s team of seasoned engineers can translate your concept into a product that is made on time and within budget constraints.
Ellex Precise’s team of seasoned engineers can translate your concept into a product that is made on time and within budget constraints. Dedicated to reducing your time-to-market while ensuring high levels of quality, you can count on Ellex Precise to explore all aspects of mechanical, software and electronics engineering design in order to deliver an inspired product design.
- Mechanical
- Software
- Electronics
2. Precision Machining
Ellex Precise commands the full range of conventional and CNC machinery, including EDM, Wire EDM, Laser, Water-Jet and Specialist Grinding.
Ellex Precise commands the full range of conventional and CNC machinery, including EDM, Wire EDM, Laser, Water-Jet and Specialist Grinding. Whether you require one-off samples or production runs of components and assemblies, Ellex Precise can meet all of your precision machining needs.
Prototyping:
Rapid production of prototype and short-run components machined to exacting standards in terms of accuracy, mechanical features, functionality and aesthetics.
Volume Production:
Precision machined parts in batch or volume manufacture, machined under tight quality control to ensuring repeatability.
Testing Services:
Detailed analysis and testing of product components against various stress, motion, vibration and heat measures will ensure your design withstands its requirements in use.
3. Tooling and Manufacturing
Our team of experienced toolmakers, combined with our extensive experience in the manufacture of medical devices, will ensure your original design concept is carried through to the end user.
At Ellex Precise, we understand the value of high quality tool making. Whether you require complex progressive dies or simple contract tooling, no project is too big or too small. Our team of experienced toolmakers, including Director Grant Tinney, pride themselves in developing die designs engineered for reliable production. Combined with our extensive experience in the manufacture of medical devices, Ellex Precise will ensure your original design concept is carried through to the end user.
Our range of tooling services includes, but is not limited to:
- Injection Moulding
- High- and Low-Pressure Casting Dies
- Investment Casting
- Stamping tools
- Blow Moulds
- Vacuum Forms
4. Project Management
Ellex Precise can provide seamless integration and management of the various elements of your commercialisation program.
Ellex Precise can provide seamless integration and management of the various elements of your commercialisation program, helping drive your innovative technologies to market on time – and on budget. Whether you require us to partner with you for tooling, automation, machined components or an assembly requiring components that are cast, moulded, stamped and/or machined, Ellex Precise can custom-tailor a project to meet your needs.
5. Regulatory Strategy and Support
Drawings on more than 25 years’ experience, Ellex Precise will help you identify and meet the regulatory requirements for your device in a number of different markets.
Navigating the regulatory landscape for medical devices can be a challenge. Drawing on more than 25 years’ of hands-on experience in the regulatory compliance of medical device technologies, Ellex Precise can help you meet the requirements of the “traditional” regulatory markets of North America, Europe and Australia, as well the emerging markets of Asia. Our expert team will identify regulatory requirements for your device and map-out the steps needed to meet these requirements in preparation for market launch and/or to access new markets. All work is undertaken in accordance with Ellex’s third-party accredited Quality System.
- Expert medical device and regulatory guidance, including device classification (Class I, IIa, IIb, and III)
- Product Registration/Regulatory Submissions:
USA, FDA
Australia, TGA
Europe, CE
Canada, Health Canada
China, SFDA
Japan, PMDA
Korea, KFDA
Taiwan, TFDA
- Technical Documentation Support:
Preparation of technical file
Guidance on clinical data requirements
Product risk assessment
Product and materials testing
Biocompatibility
Sterility validation
Software validation
Electrical safety
With extensive links to the technology, engineering and manufacturing communities in Australia, the Ellex Precise team has the experience and expertise needed to successfully drive your medical technology commercialisation program.
|
Grant Tinney (Director)
Grant Tinney is Chief Executive of the Precise Advanced Manufacturing Group (PAMG), a family of privately-owned businesses specialised in mould/die manufacture, component and assembly manufacture, automation and engineering services, as well as precision machining. Grant started his professional career as a toolmaker and over the past 15 years has focused on a number of business and strategic development initiatives in order to grow the reach of PAMG to encompass the defence, aerospace, mining, medical and renewable energy sectors. An active member of many industry and government associations, Grant currently serves on the Board of the Manufacturing Consultative Committee (MCC). He holds an Associate Diploma in Engineering and Business Studies.
|
|
|
Tom Spurling (Director)
Tom Spurling is the Group Chief Executive Officer of Ellex Medical Lasers Limited, an ASX-listed manufacturer and distributor of ophthalmic technology with annual revenues of over $45 million. Tom has extensive experience in new business development across the defense and commercial markets both in Australia and internationally. He previously served as Managing Director and General Manager of Tenix LADS Corporation, technology originally licensed by Tenix from the Australian Department of Defence. He holds a Degree in Economics and is a chartered accountant.
|
 |
|
Don Watton
Don Watton is Vice President of Quality for Ellex Medical Pty Ltd, directing the Company’s global quality and regulatory program. With a strong background in biomedical engineering and over 25 years’ experience in medical device regulatory management, he has extensive expertise across a number of medical device development and commercialisation programs. Don has operated a regulatory consultancy business for several years, helping both local and international clients formulate regulatory and quality strategies for the medical device market, and has assisted in the development of ISO13485 Quality Management Systems. Don also has experience in the preparation and administration of government R&D grants.
|
 |
|
Victor Previn
Victor Previn is a professional engineer and one of the original founders of Ellex Medical Lasers Limited. With a career spanning more than 25 years in the laser industry, Victor was responsible for developing and commercialising the medical laser technology platform that now forms the core of Ellex’s product portfolio. He has spent more than 15 years in the ophthalmic laser industry in a business development capacity and has served as Chairman of the Ellex Board of Directors since 2005. He holds a degree in Engineering.
|
 |
|
Please click here to submit an enquiry