Elevate MedTech
Elevate MedTech is a New Zealand-based regulatory consultancy formed from Johner Institute New Zealand, Practical QA/RA and Svante Medical. Its team supports medical devices and SaMD across Europe, the United States, the UK, Australia and New Zealand. Services include regulatory strategy, technical documentation, quality systems, software lifecycle work, cybersecurity and in-country representation.
Learn more
Medizinprodukteberater Course: Requirements, Tasks, Responsibilities
Dr. Oliver Eidel
30 views
·
7 months ago
MDCG guidance
MDCG 2025-9: Breakthrough devices (BtX)
The EU framework for designating medical devices and IVDs as breakthrough technologies, obtaining expert advice and planning proportionate evidence.
Other
Endorsed Dec 2025
Medizinprodukteberater Course: Examples
Dr. Oliver Eidel
29 views
·
7 months ago