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| Client organisation | Services provided | Contact person | |
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Heart Smart DiagnosticsDesigner and anufacturer of leading edge cardiac analysis equipment. | Review and advise on conformance to TG(MD) Regulations. Risk analysis and product market and engineering advice. Act as agent for device applications. |
Dr. Jack Minas Managing Director jack@hsd.net.au ph: +61 3 9855 9555 |
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Care EssentialsSpecialist manufacturer of patient warming devices and accessories. | Review, audit and revise ISO 13485:2003 QMS to TG(MD) and EEC Regulations. Risk analysis and product market and engineering advice. |
Lynda Holdsworth Quality Manager lyndaholdsworth@careessentials.com.au ph: +61 3 9562 7713 |
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AlimtypeManufacturer of surgical devices and electrosurgical accessories. | Review, revise and implement ISO 13485:2003 full QMS to TG(MD) Regulations - TGA device conformity certification of Class IIb devices. Act as agent for devcice applications. |
Colin Trewavis Managing Director ctrewavis01@optusnet.com.au ph: +61 3 9761 9342 |
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Grey InnovationLeading edge product development for the automotive, medical and consumer device markets. | Regulatory requirements and Engineering advice for medical device product development activities. |
Jefferson Harcourt Managing Director jefferson.harcourt@greyinnovation.com ph: +61 3 9692 6999 |
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Daniels InternationalA leader in the development and manufacture of devices for the handling of medical sharps. | Build and implementation of ISO 13485:2003 full QMS to TG(MD) Regulations and MDD Annex II - TGA device conformity certification - MDD device certifications. |
Neil Wright Supply Chain Manager NWright@danielsinternational.com ph: +61 3 9797 5646 |
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OptiscanWorld leading developer and manufacturer of miniaturised confocal microscopy devices. | Build and implementation of ISO 13485:2003 full QMS to MDD Annex II and CMDCAS - MDD device certifications - GMP and NRTL certifications. |
Matthew Barnett Chief Executive Officer matthewb@optiscan.com ph: +61 3 9538 3333 |
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ITL CorporationManufacturers of innovative medical devices and procedure packs for global healthcare markets. | Device assessment and regulatory classification reports for US and European markets |
Martin Stonebridge Engineering Manager martin.stonebridge@itl‑limited.com ph: +61 2 6280 8535 |
