Market Access (AUS) Pty Ltd (MA) is an independent provider of product compliance to manufacturers and distributors of electrical, medical and electronic devices. Their specialist and highly experienced team will ensure your products conform with all applicable Australian regulatory requirements to not only minimize any risk of liability, but assist your rapid time to market.
MA only employs highly qualified professionals with extensive regulatory and product standards experience, including former European testing and technical certifiers, senior telecom, electromagnetic compatibility (EMC) radio frequency and safety testing engineers, quality systems auditors and regulatory affairs experts. MA are specialists in product compliance and can help you determine the right regulation and conformance requirements for your product to help minimize your liability, and get your product to market quickly and cost effectively.
Contact MA to discuss your product conformance requirements with an expert.
Gunther Theisz, MSc
Managing Director and founder of MA
Gunther Theisz has a Masters degree in electrical engineering and more than thirty years experience in testing and certification for a wide range of electrical and electronic equipment, including machinery, household appliances and information technology devices. Having worked as a technical certifier and quality systems auditor for TUV SUD, one of the largest Notified Bodies in Europe, Gunther has also worked in Frankfurt, Tokyo and Hong Kong before moving to Sydney, Australia in 1999. Gunther has managed the testing laboratories for Austest and Testing and Certification Australia (TCA). He is a former chair of ECTA (testing laboratories) and REAB (Certification bodies).
Gunther was involved with international advisory projects for the government in Abu Dhabi, United Arab Emirates, the APEC Policy Support Unit in Singapore and the United Nations Industrial Development Organization (UNIDO).
Val Theisz,
Principal Consultant, Co-founder and non-executive Director
Val Theisz is a regulatory affairs professional with over 15 years of experience in medical devices of all risk classes, including life-sustaining, high-risk active implantables, and software as medical devices (SaMD) using Artificial Intelligence (AI) algorithms. Val has a Masters degree in electrical engineering (MSc) and holds Regulatory Affairs Certification credentials for EU and US regulations (RAC EU, RAC US) from the US-based Regulatory Affairs Professionals Society (RAPS). Val is one of the few RAPS Fellows based in Australia. Val has been a member of the UK Journal of Medical Device Regulation (JMDR) Editorial Board since 2019. She authored the book ‘Medical Device Regulatory Practices: An International Perspective’ available through CRC Press.
Before moving to Australia, Val worked as a test engineer, project manager, QMS auditor, and Technical Certifier (Reviewer) with TŰV Product Service (currently TŰV SŰD) in Frankfurt/ Main, Germany, Tokyo, Japan, and Hong Kong. After moving to Australia in 1999, Val held regulatory management positions in both established and start-up companies in Australia: Polartechnics, ResMed, Ventracor, Pfizer, Cochlear, Annalise AI. Val has also been the Director of Regulatory & Clinical Affairs, Code of Practice with the Medical Technology Association of Australia (MTAA), leading industry advocacy initiatives with the Therapeutic Goods Administration (TGA) and the Australian Department of Health.
Val’s experience within the field covers the entire product lifecycle: regulatory strategy; verification and validation (V&V); testing and compliance to international standards; clinical trials for high-risk innovative medical devices; submissions and pre-market approvals in established markets (CE Marking, FDA 510(k) and PMA, TGA registration, Health Canada licences); and post-market ongoing compliance. Her experience spans the major markets of the EU, USA, Australia and Canada.
Jane Wright
Jane Wright has over 20 years’ experience in Office Management, Administration and Accounts over a wide range of businesses. Jane enjoys the challenges of developing and implementing new systems, motivating a team and providing customers with timely and efficient service. Her role with Market Access as office manager will provide ongoing support to all stakeholders throughout the organisation.
Alfred Pang
Technical Reviewer and Assessor
Alfred has been with MA for a number of years in the roles of technical reviewer and assessor for due diligence reviews.
Alfred has a Higher Certificate in Electrical Engineering from the Hong Kong Polytechnic and an Advanced Certificate in Industrial Electronics from TAFE. Previously, Alfred has been engaged in testing to a wide range of national, international and technical standards for electrical appliances as well as extensive client liaison with regards to non-compliances and assessment of overseas test reports to local approval requirements. With over 30 years knowledge and experience he is a valuable member of the MA team providing a quality service to our clients.
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