Elevate MedTech
An international QARA consultancy with a Cambridge presence, delivering practical compliance solutions.
Three independent experts from three countries unite 60+ years of diverse expertise—pooling knowledge for comprehensive support in QARA consulting, fractional resources, SaMD, workshops, EC-Rep, UKRP, and AU/NZ sponsorships. Our qualified clinician provides essential customer and clinical insights.
We present at global conferences, teach QA/RA at university levels, and actively shape industry standards through professional organisations and legislative collaboration.
Recognising that no single Quality and Regulatory consultant knows it all inspired three previously independent yet experienced consultants to pull resources and knowledge and join forces.
Elevate MedTech was formed in October 2025 by merger of Practical QAQA (Cambridge, UK) operated by Dr Stephen Smith, Johner Institute NZ (NZ) operated by Anne Arndt, and Svante Medical (Australia) operated by Dorrin Asefi. Clinical insights are provided by Dr Maria Vella, a UK based consultant Obstetrican and Gynaecologist
Whether you’re starting out or scaling globally, by utlising our extensive resource base we offer practical, audit-ready and clinically viable solutions that move with the speed of your business.
Practical Medical Device QA and RA solutions when needed.
Products and services
Fractional Quality Assurance and Regulatory resource
If you are a start-up and not yet in need of a full-time QA and/or RA resource then we can provide resource from a few hours to a few days per week to setting up an entirely certified QMS and compiling technical documentation and regulatory submissions. We have experience in many global jurisdictions including EU (MDR/IVDR), FDA, TGA.
We can also offer clinical reviews as required to ensure your device is, and remains clinically viable through the development process.
Equally, if you have no idea what you may need, contact us and we will help you.
Quality, Regulatory and Clinical Consulting
We provide strategic business consulting services to help organisations optimise their QA and/or RA operations.
We offer
- Ad-hoc or ongoing advice
- Document preparations such as;
- Risk assessments/reports,
- Clinical assessments/reports
- Literature research
- PMS
- Problem solving
- Independent auditing
- Training (Risk, ISO13485, GMP)
If your organisation is in need of a clinical resource we can also assist.
Country Representation and Sponsorship
We are able to offer the following services:
- Manufacturer PRRC service to micro and small manufacturers
- EU Authorised Representation though presence in Malta
- UK Responsible Person
- New Zealand Sponsorship with presence in Hamilton (NZ)
Remediation or Audit Preparation work
If you have had a bad audit and have corrective actions within your QMS or submission documents to resubmit we can help.
With expertise in Root Cause Analysis, risk management and corrective actions we can help address any issues that are found.
We are also able to provide an independent review of any current documentation or processes.
Independent Auditing and Technical Reviews
In most start-ups everone is involved with everything - as it should be. Many SME's struggle to find someone who is truly independent to audit specific areas as is required by QMS regulations.
We can help plan, conduct some or all of your internal and/or supplier audits. Being independent we will see things as a regulator would likely see them.
In start-ups you can get too close to what you are doing and not see the wood for the trees so having an independent review of technical documentation is important.
Independent Design Reviewer
Similar to auditing, having that Independent Design reviewer is not only a regulatory requirement but also makes sense. Too often companies have an independent reviewer who is merely there to tick a box without realising this approach could come back to haunt them. Independent reviewers need to be exactly that, independent, and not be afraid to ask questions that may not be obvious as this is exactly what a regulator will do.
