Meet your medical device regulatory consultants

Anne leads Elevate MedTech’s ANZ operations, helping medtech innovators navigate regulatory requirements and bring products to market in Australasia and Europe. She is a certified SaMD expert witness specialising in regulatory affairs, quality management systems, and multi-jurisdictional strategy.

After years of being challenged by scientists asking why this rule, Stephen wrote his PhD on exactly that question. With 25 years across start-ups and multinationals, he brings a pragmatic, risk-based approach to compliance grounded in real experience rather than theory.

Dorrin is a product development engineer and regulatory strategist who combines hands-on R&D execution with clear, pragmatic compliance strategy. Based in Sydney, she brings extensive TGA experience across medical devices, software and combination products, from first-time QMS builds to post-market systems.

Maria is the clinician on the team, a practising Consultant Obstetrician and Gynaecologist with 25 years of hands-on experience. An award-winning subspecialist in Urogynaecology trained at King’s College Hospital, she specialises in identifying the clinical risks that are easy to overlook in early design phases.

Theodore was working on AI and machine learning in medical devices long before it was all the rage. With a PhD in Biomedical Engineering and his own SaMD company, he knows first-hand what it takes to get AI-driven products through regulators across the US, EU, Australia, Japan and beyond.

With 15 years across startups and multinationals, Happy brings a practical, no-nonsense approach to quality and regulatory challenges. An ASQ Certified Quality Engineer and ISO 13485 Lead Auditor, she covers design controls, risk management and QMS across ISO 13485, FDA and EU MDR.

Based in Wellington, Victor brings 10 years of quality management experience and a Master’s in Biomedical Engineering. A certified auditor with hands-on experience across ISO 13485, 9001, 14001, 45001, 27001 and MDSAP, he is Elevate’s go-to for QMS across the New Zealand market.

With experience at Apple, PwC and Fisher & Paykel among others, Tyler brings big tech, management consulting and clinical engineering to Elevate. Currently building his own machine learning system for ICU critical care, he knows exactly what it takes to bring AI-driven devices to market.

With nearly 20 years of medical writing experience at companies including Medtronic and Amgen, Tim is Elevate’s expert for turning complex clinical evidence into clear, publication-ready content. An ELS certified editor, he covers everything from journal articles to clinical evaluation reports.

As Elevate’s biocompatibility partner, Hendrik of BiocompTox has spent his career focusing exclusively on in vitro biocompatibility and toxicology, one of the most critical and often overlooked stages of device development. When questions about ISO 10993 arise, he is the right person to ask.