Build internal expertise to meet UKCA, TGA & Medsafe requirements

Whether you’re developing medical devices or SaMD, regulatory success depends on in-house understanding of classification, compliance, and documentation. Our MDR training formats are designed to bridge the gap — with practical tools, real-world cases, and regional insights tailored to your market.

We cover essential standards and topics like:

  • Medical Devices Classification & Regulations
  • SaMD Documentation (IEC 62304, IEC 62366-1)
  • Cybersecurity & Risk Management
  • Submission strategies for UK, Australia, and New Zealand
  • Audit readiness and QMS alignment
  • Delivered by seasoned consultants — online, in-house, or at select training events.
Build internal expertise to meet UKCA, TGA & Medsafe requirements

Upcoming Medical Devices Regulatory Workshops & Events

October 15, 2025 – SaMD Classification & IEC 62304 Essentials (Live Online)

A practical introduction to IEC 62304, local classification logic, and documentation strategies for UKCA, TGA, and Medsafe.

→ No prior regulatory knowledge needed. Ideal for product, QA, or regulatory teams.

10:00–13:30 UK / 20:00–23:30 AEST
Limited seats – includes slides & Q&A session

November 5, 2025 – In-House Training: Build Your Regulatory Roadmap (On-Site)

December 3, 2025 – Live Webinar: Medsafe vs TGA vs UKCA – Key Differences

January 22, 2026 – Workshop: Building a Submission-Ready Technical File

February 12, 2026 – Webinar: SaMD Compliance – From Classification to Validation

March 4, 2026 – Workshop: Cybersecurity in Medical Devices – TGA, UKCA, Medsafe

Build internal expertise to meet UKCA, TGA & Medsafe requirements

In-House Training for Medical Device & SaMD Compliance

Bring regulatory expertise directly into your company – with tailored training sessions designed for your team’s needs. From MDR to UKCA, TGA and Medsafe: we help your staff understand key requirements, build practical skills, and stay audit-ready through interactive, real-world learning.

Practical MedTech Regulatory Know-How – Delivered On Site or Online

From hands-on workshops to tailored in-house training – get actionable insights on medical device and SaMD compliance for the UK, Australia, and New Zealand.

Looking for more? Discover how we support your team beyond consulting.

Regulatory Training for Your Team

Regulatory Training for Your Team

Build internal know-how with workshops, online courses, and our Regulatory Accelerator.

Helpful Ressources

Helpful Ressources

Access blog articles, checklists, and updates for UKCA, TGA, and Medsafe.

The People Behind Elevate MedTech

The People Behind Elevate MedTech

Learn who we are and why MedTech teams trust us across UK and APAC.