Certification Body Australia (CBA) is an independent provider of product compliance and inspection services to manufacturers and distributors of electrical 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.
CBA is an officially accredited certification body conforming to the requirements and procedures of the following agencies:
– The Queensland Electrical Safety Office, Electrical Equipment Safety Scheme (EESS) and NSW Recognised External Approval Schemes (REAS)
– Joint Accreditation System of Australia & New Zealand (JAZ-ANZ), for Conformity Assessment Bodies providing Product Certification Services and the Telecommunications Equipment Certification Scheme(TECS) for Telecom Products
CBA only employs highly qualified professionals with extensive regulatory and product standards experience, including former European testing and certification body technical certifiers, senior telecom, electromagnetic compatibility (EMC) radio frequency and safety testing engineers, quality systems auditors and regulatory affairs experts.CBA are specialists in product compliance and certification services with all revenue fully funded through the provision of product compliance and certification services.CBA 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 CBA to discuss your product conformance requirements with an expert.
Gunther Theisz, MSc
Managing Director and founder of CBA
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).
Co-founder and non-executive Director
Val Theisz is a Regulatory Affairs professional with over 15 years experience in medical devices of all risk classes, including life-sustaining, high risk active implantables and software as meidcal devices (SaMD) using artifical intelligence (AI) algorithms. Val has a Masters degree in electrical engineering and holds Regulatory Affairs Certification credentials for EU and U.S. regulations (RAC EU, RAC US) from the U.S.-based Regulatory Affairs Professionals Society (RAPS). Val is one of the two RAPS Fellows based in Australia. She authored the book ‘Medical Device Regulatory Practices: An International Perspective’ published by CRC press. Val is a member of the Editorial Advisory Board of the UK-based Journal of Medical Device Regulation (JMDR) published by the Global Regulatory Press.
Before moving to Australia in 1999, Val worked for seven years with one of the largest EU Notified Bodies in Germany as test engineer, project manager, quality system auditor, technical certifier/reviewer and medical device auditor in Frankfurt am Main, Hong Kong and Japan.
In Australia, Val held regulatory management positions in both established and start-up companies: Resmed, Ventracor, Pfizer Australia, Cochlear and the Annalise AI. Between 2015 and early 2021 Val served as Director of Regulatory, Clincial & Code of Paractice at the Medical Technology Association of Australia (MTAA) leading MedTech Industry advocacy initiatives with the TGA and the Australian Department of Health. Val’s experience within the field covers the entire product life cycle: regulatory strategy; verification and validation (V&V); testing and compliance to international standards; clinical trials for high-risk innovative medical devices; regualtory submissions in established markets (CE Marking certifications to EU MDD and MDR, FDA 510(k)s and PMAs, TGA registrations, Health Canada licences); and post-market ongoing compliance. Her experience spans the major markets EU and US, as well as, Australia, Canada and ASEAN countries.
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 Certification Body Australia as office manager will provide ongoing support to all stakeholders throughout the organisation.
Colin is an experienced regulatory professional with expertise in equipment regulation, product compliance and standards development. He has over thirty years’ experience in product compliance, including 14 years with the Australian Communications and Media Authority (ACMA). Colin has been a member of a number of Standards Australia and Communications Alliance working committees.
Sergei is an experienced engineering professional with expertise in certification, testing, product compliance, data analysis and hardware design. He has a Bachelor of Electrical Engineering and has been a member of various working committees in Communications Alliance (former ACIF-forum for Telecomms industry) for over 20 years. Sergei was involved in developing of many ACIF/ AS/CA Telecomms standards. Sergei is providing assessment and review to the JAS-ANZ Telecommunications Equipment Certification Scheme (TECS).
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