Elevate MedTech
We're a Quality Assurance and Regulatory Affairs (QARA) consultancy with roots in Cambridge, delivering practical compliance solutions to medical device and IVD companies.
Internationally experienced. International presence.
Our co-founder, Dr. Stephen Smith, is Cambridge-based, and our wider team unites independent experts across three countries, bringing 80+ years of combined QARA expertise to the medtech community. We pool that knowledge to provide comprehensive support to device companies in Cambridge and across the UK — backed by an international perspective that keeps your compliance strategy globally relevant.
From Cambridge Science Park to the city's growing cluster of medical device and software innovators, we work hands-on with local companies at every stage. Whether you're a Cambridge startup pursuing ISO 13485 or ISO 42001 certification, a SaMD developer navigating regulatory approval, or a scaling device company needing fractional QA/RA support, we deliver pragmatic solutions built around your needs — right here in Cambridge.
Elevate MedTech is an international medical device and Software as a Medical Device (SaMD) regulatory and quality consultancy. It was formed in October 2025 through the merger of three established firms: Practical Quality and Regulatory (Cambridge, UK), Johner Institute New Zealand, and Svante Medical (Australia). The combined entity brings over 60 years of expertise and maintains offices in Cambridge (UK), Christchurch (New Zealand), and Sydney (Australia).
The company helps MedTech innovators, startups, scale-ups, established manufacturers, and investors navigate regulatory pathways to market approval and ongoing compliance. It covers key markets including Europe (MDR/IVDR, CE Marking), the United States (FDA 510(k), De Novo, QMSR, PMA), the United Kingdom (UKCA Marking, MHRA), Australia (ARTG Inclusion, sponsor representation), New Zealand (WAND Notification, sponsorship), and Asia.
Strong Cambridge Roots and Presence
Elevate MedTech retains a firm base in Cambridge and the broader Cambridge Cluster. Its UK operations continue to be led from Cambridge by the team from the former Practical Quality and Regulatory. While expanding internationally, it remains “firmly rooted in Cambridge” and committed to the pragmatic advice clients trust.
Cambridge-based leadership includes;
- Dr Stephen Smith: Operates the Cambridge/UK side. Fellow of the Chartered Quality Institute (CQI) and TOPRA. Over 25 years in QA/RA for medical devices, covering ISO 13485, ISO42001, FDA 21 CFR Part 820, MDSAP, global submissions, post-market surveillance, and third-party audit preparation. He is involved in teaching (including TOPRA MSc modules) and industry standards work.
- Dr Maria Vella: UK-based consultant obstetrician and gynaecologist (subspecialty in urogynaecology). Provides clinical insight and reviews to ensure devices remain clinically viable.
This Cambridge presence positions the firm within one of Europe’s leading life-sciences and MedTech ecosystems, supporting local startups and SMEs while offering global reach.
Core Services
Services are structured around two main tracks—training/workshops and consulting/support—with flexibility for clients at any stage:
- Regulatory strategy and consulting — Classification, technical documentation, submissions, gap assessments, and full pathway support.
- Quality management — ISO 13485 QMS implementation/maintenance, QMSR readiness (aligned with FDA’s 2026 changes), internal/supplier auditing, remediation, and independent design reviews.
- SaMD and software focus — Deep expertise in IEC 62304, cybersecurity, software lifecycle, and related standards.
- Training and capability building — Hands-on workshops, 1-on-1 coaching, seminars (MDR, IEC 62304, ISO 13485, ISO 14971).
- In-country representation and roles — UK Responsible Person (UKRP), Australian TGA sponsor, New Zealand sponsor, EU Authorised Representative, and external Person Responsible for Regulatory Compliance (PRRC)/QMR roles (especially useful for micro/small manufacturers).
- Clinical and specialised support — Clinical evaluations/reviews (leveraging the in-house clinician), biocompatibility/toxicology advisory, human factors, due diligence for investors, and commercialisation/go-to-market strategy.
- Flexible options — Free initial consultations, micro-consulting for specific blockers, fractional QA/RA resource, and digital tools (Regulatory Radar and Post-Market Radar).
The firm emphasises practical, audit-ready, and clinically informed advice rather than purely theoretical guidance. It serves startups needing early regulatory strategy, established companies expanding markets or closing compliance gaps, and investors seeking regulatory-readiness assessments
The team presents at conferences, teaches at university level, and contributes to industry standards.
Positioning and Approach
Elevate MedTech markets itself as a pragmatic partner that combines regional depth (strong APAC and UK expertise) with global coverage. It targets the full journey from concept/classification through market access and post-market obligations. Recent activities include website relaunches organised around markets and product stages, workshops (e.g., on medical software regulatory requirements and ISO 14971), and participation in events such as Innovate Western Sydney, AusMedtech, MedTech World (Malta), and others.
https://elevate-med.tech/
Contact: Free consultation available via the site; general enquiries to [email protected].
In summary, Elevate MedTech is a newly consolidated, specialist MedTech regulatory consultancy with genuine Cambridge roots and leadership, offering practical support for getting medical devices and SaMD to market across major global jurisdictions while remaining embedded in the Cambridge innovation ecosystem.
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.
