In response to the growing complexity of medical devices and regulatory challenges, we are proud to announce a powerful new alliance. Practical Quality and Regulatory (Cambridge) has united with the Johner Institute (NZ) and Svante Medical (Australia) to form Elevate MedTech.
Our new structure is built on a core belief: no single consultant can know everything. Elevate MedTech brings together a diverse team with decades QA/RA experience, complemented by a qualified clinician to ensure the voice of the customer guides every project. Together as Elevate Medtech, we’ll cover the full pathway from design to compliance and market access.
We offer:
- Regulatory consulting and training – MD, IVD, SaMD, QMS, cybersecurity, human factors, technical documentation.
- QA/RA and clinical consulting – Fractional QA/RA, audit preparation, independent reviews.
- International supplier auditing - we have qualified auditors in both hemispheres.
- Clinical insight from a practising UK consultant.
- Biocompatibility and toxicology consulting.
- Due dilligence assessments.
- Trusted TGA sponsorship in Australia and sponsorship in NZ.
- Digital tools – Regulatory Radar and Post-Market Radar.
- Commercialisation strategy and go-to-market support for MedTech, Digital Health, and BioPharma.
We pride ourselves in offering honest pragmatic advice to our clients. Whilst our Cambridge /UK operation will still be operated by Dr. Stephen Smith and Dr. Maria Vella, we believe that our enhanced services and access a wider pool of specialised knowledge offers clients a more streamlined and cost effective pathway to compliance.
