Johner Institute New Zealand, Practical QA/RA, and Svante Medical are joining forces. From October 2025, we will continue together as Elevate Medtech. This brings our strengths under one roof and allows us to support you more broadly across New Zealand, Australia, the UK, the US, and the EU.
Frequently Asked Questions – Our new name: Elevate Medtech (effective October 2025)
What does the new name mean?
Elevate Medtech reflects our shared mission: to raise the standards of compliance and innovation in medical technology, and to support our clients at every step of the pathway to market.
What expertise does Elevate Medtech bring together?
- Regulatory consulting and training, including SaMD, IVD, QMS, cybersecurity, human factors, and technical documentation.
- Pragmatic QA/RA and clinical consulting, from fractional QA/RA support to audit preparation.
- Clinical insight from an experienced medical specialist (obstetrics and gynaecology).
- Biocompatibility and toxicology consulting for medical devices.
- Internal audits, including supplier audits
- TGA sponsorship and regulatory representation in Australia.
- UK Representative
- NZ sponsorship
- Innovative digital tools, including Regulatory Radar and Post-Market Radar.
- Regulatory due diligence for companies and investors.
- Commercialisation and go-to-market strategy for MedTech, Digital Health, and BioPharma.
Who is in the Elevate Medtech team?
Our team brings together regulatory, quality, clinical, biocompatibility, and commercial expertise:
- Anne Arndt
- Regulatory affairs & quality management systems (ISO 13485, MDSAP, CFR Part 820 & Part 11)
- SaMD expertise and training programmes
- Expert Witness for Software as a Medical Device (No. 1-22-1016)
- Certified Medical Device Auditor (0910053280BDPP)
- Dorrin Asefi
- QMS implementation and maintenance (ISO 13485, ISO 9001, GLP, 21 CFR Part 820 & Part 11)
- TGA sponsorship and regulatory representation in Australia
- Technical documentation, submissions, post-market vigilance
- Mechanical and software verification & validation (V&V)
- Dr. Stephen Smith
- 25+ years in QA/RA for medical devices
- Quality management systems (ISO 13485, FDA 21 CFR Part 820, MDSAP, ISO 42001)
- Third Party audit preparation
- Global submissions
- Post-market surveillance
- Dr. Maria Vella
- Consultant obstetrician & gynaecologist, subspecialty in urogynaecology
- Clinical risk assessment and medical insight in device development
Associated experts working with us:
- Hendrik Rudolf
- Biocompatibility and toxicology specialist
- In vitro biological safety evaluation of medical devices
- Craig T. Ingram (USA)
- Commercialisation strategist in MedTech, Digital Health & BioPharma
- Go-to-market, adoption, and growth strategy with 3 successful exits
Will my contacts change?
No. Your current contacts remain the same. The people you work with today will still be your points of contact tomorrow.
What are the new email addresses?
From 6 October 2025 you will reach us under @elevate-med.tech:
- Anne Arndt – Anne.Arndt@elevate-med.tech
- Dorrin Asefi – Dorrin.Asefi@elevate-med.tech
- Dr. Stephen Smith – Stephen.Smith@elevate-med.tech
- General enquiries – info@elevate-med.tech
All existing email addresses will continue to work and forward automatically.
What about phone numbers, office addresses, and billing address?
All phone numbers and office addresses remain the same. Because the company name will change to Elevate Medtech our emails will as well.
sponsor-aus@elevate-med.tech
What about the websites?
Our new website will go live on 6 October 2025. The existing domains (Johner Institute NZ, Practical QA/RA, Svante Medical) will redirect you there.
What happens to my ongoing projects and contracts?
Nothing changes. All existing contracts, offers, and ongoing projects continue as agreed.
Do invoices or bank details change?
No. Invoices and payment details remain the same. Only the brand name will change to Elevate Medtech.
Need updated contracts or NDAs?
If you require new contracts, NDAs, or other formal documentation reflecting the Elevate Medtech name, please let us know – we will provide them promptly.
What happens to my Medical Device University subscription?
Your subscription continues without any change. Access, content, and billing remain the same.
What about my Regulatory Radar or Post-Market Radar subscriptions?
No changes. Your subscriptions, alerts, and login credentials stay valid.
Do I need to re-register for seminars or workshops I’ve already signed up for?
No. All your seminar and workshop registrations remain valid. Dates, content, and confirmations do not change.
What about sponsorship in New Zealand and Australia?
Our role as a trusted sponsor/in-country representative continues without interruption. All existing registrations remain in place.
Do legal entities or registrations change?
No. Legal entities remain the same. Only the brand name will change.
Who can I contact if I have more questions?
Please reach out to your usual contact person. All current phone numbers and email addresses will remain in use. From 6 October you can also contact us via our new general address: info@elevate-med.tech
