TCA plans to expand further beyond the traditional areas of electrical safety and EMC, to cover more aspects of medical device safety according to the “Essential Principles” of the new Therapeutic Goods (Medical Devices) Regulations 2002, which are based on the “Essential Requirements” of the European Medical Device Directive (MDD).

Peter Selvey, who returns to Australia after four years experience working for TUV Product Service Japan, will support this new direction. Throughout Asia/Pacific region, he worked as a Notified Body technology auditor and test engineer covering a wide range of active (electrical) medical devices. He also specialized in “performance” and “functional safety”, two very important fields for active devices.

Performance includes items such as clinical accuracy, stability, control of energy/flow rates, provision of alarms and ability to withstand the clinical environment. Functional safety involves assessing protection systems, usually CPU based, in higher risk devices such as dialysis systems, infusion pumps, incubators and surgical lasers. The new “Essential Principles” concept requires manufacturers to address these areas even where published standards are not available.

With the new focus on “Essential Principles”, TCA can now provide:

• device specific guidance on applicable TGA/MDD requirements, based on the Essential Principles and current published standards
• support over whole design process (initial idea to production)
• general guidance on risk management, functional safety
• technical file reviews (review of manufacturer’s evidence of compliance with TGA/MDD essential principles)
• support for specialized testing (unusual IEC/ISO/EN standards, manufacturer’s specifications)
• on-site seminars (practical implementation of MDD/TGA requirements, practical design for IEC60601-1, design control, risk management, functional safety)