We’re an international partnership of regulatory consultants from New Zealand, Australia, and the United Kingdom — united under Elevate MedTech to help MedTech startups and established manufacturers bring medical devices and SaMD to market with clarity and confidence.

We combine deep regional expertise with global experience to guide you through classification, compliance, documentation, and post-market strategy — tailored for UKCA, TGA, and Medsafe.

Whether you’re starting out or scaling globally, we offer practical, audit-ready solutions that move with the speed of your business.

Our Founding Partners

Anne Arndt

Anne Arndt, New Zealand

Based in Christchurch, Anne leads Elevate’s regulatory consulting for Medsafe. With a background in clinical engineering and quality systems, Anne has supported both local startups and multinational companies in aligning with New Zealand’s evolving compliance landscape.

Stephen Smith, UK

Based in London, Stephen specialises in UKCA, MHRA interactions, and PRRC roles. His experience spans SaMD classification, cybersecurity, and notified body submissions, helping UK and international firms navigate post-Brexit regulatory changes.

Dorinn Asefi

Dorrin Asefi, Australia

Located in Sydney, Dorrin brings extensive TGA experience across medical devices, software, and combination products. Known for her clear strategies and pragmatic execution, she supports clients with technical documentation, risk management, and post-market systems.

Our Team

Dr Maria Vella

Dr. Maria Vella

Maria is a Consultant Obstetrician and Gynaecologist and brings a necessary clinical eye to the table. In her 25 years clinical experience she has seen great medical devices that she has used repeatedly and ones which she has tried once and never used again – whilst also telling colleagues of the experience.

Maria knows what clinicians want and what they don’t, and most importantly knows what may present a clinical risk which many companies fail to consider, particularly in early stages.

Maria completed a two-year research fellowship in Urogynaecology with Professor Linda Cardozo at Kings College Hospital, London, followed by a three-year subspecialty program in urogynaecology. She has a passion for research and has been involved in the publication of many papers which are widely cited. She is often invited to peer reviews has presented at national and international meetings and written a number of book chapters.

Maria received recognition for best free paper in 2006 by the International Urogynaecological

Association, and again in 2012 by the European Urogynaecology Association. She is also a college tutor in charge of trainees in obstetrics and gynaecology.

Victor Meyer

Victor Meyer

Based in Wellington, Victor has accumulated 10 years of experience in the quality management systems field. He holds a master’s degree in biomedical engineering and possesses auditor certifications, along with hands-on experience across multiple standards, including ISO 13485, 9001, 14001, 45001, 27001, and MDSAP.

How We Work

Step 1

Initial Contact

We get in touch within 1–2 business days to understand your product, goals, and regulatory status.

Step 2

Planning

We analyse your current documentation or starting point, then design a roadmap tailored to your product type, markets, and timeline.

Implementation

We build or improve your technical file, manage regulatory interactions, and support your team through workshops, review calls, or full-service engagements.

Support

After approval, we help maintain compliance with updates, audits, post-market obligations, and ongoing team training.

Let’s Elevate Your Regulatory Strategy

Work with a team that combines startup agility with deep regulatory knowledge across the UK, Australia, and New Zealand. From technical documentation to training and in-country representation — we’re here to help you succeed.