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

Stephen leverages decades of compliance expertise from his base near Cambridge, providing strategic guidance to organisations on quality systems, risk management, and global regulatory pathways (FDA, UKCA, CE Marking, TGA). His approach is rooted in pragmatism, ensuring robust and efficient compliance. A Fellow of the CQI and TOPRA, Stephen also holds a PhD and two MSc degrees. He is committed to advancing the profession through mentoring and lecturing.

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, a Consultant Obstetrician and Gynaecologist based near Cambridge, UK, bridges the gap between clinical practice and medical innovation.

Her 25-year career provides unparalleled insight into what clinicians truly need, ensuring products are practical, safe, and effective. She specialises in anticipating critical clinical risks that can be missed during early design phases.
Awarded for her research by both the International and European Urogynaecological Associations, Maria is an accomplished academic and subspecialist. She completed advanced training in Urogynaecology at King’s College Hospital, London, and now shares her expertise as a published author, international presenter, and dedicated College Tutor for trainee doctors.

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.