Elevate Medtech
Elevate Medtech WebsiteStandort
- Stadt:
- Christchurch
- Bundesland/Provinz:
- South Island
- Land:
- Neuseeland
Branche
- Gesundheits- und Sozialwesen
- Biotechnologie und Life Science
Über
As of 6 October 2025, Johner Institute New Zealand, Practical QA/RA, and Svante Medical have joined forces and operate under the name Elevate Medtech.
What’s new:
Together as Elevate Medtech, we cover the full pathway—from design and compliance to sponsorship in NZ and Australia, through to international market access in Australia, New Zealand, the UK, the USA, and the EU.
- Regulatory consulting & training – SaMD, IVD, QMS, cybersecurity, human factors, technical documentation.
- QA/RA and clinical advisory – fractional QA/RA, audit preparation, independent reviews.
- Clinical insights from a practising physician.
- Biocompatibility and toxicology advisory.
- Recognised TGA sponsorship in Australia and sponsorship in NZ.
- Commercialisation strategies and go-to-market support for MedTech, digital health, and biopharma.
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.