- Confusion about SaMD classification
Each authority — MHRA, TGA, and Medsafe — applies different logic to Medical Device Software Classification, making it hard to define the right pathway. - Uncertainty around technical requirements
Software lifecycle (IEC 62304), usability (IEC 62366-1), and cybersecurity expectations differ between regions. - Documentation gaps
Missing traceability, validation, or clinical justification delays your UKCA, TGA, or Medsafe submission. - Limited in-house regulatory expertise
Internal teams are often focused on development – not regional regulatory nuances.
Compliance strategies tailored to regional SaMD compliance requirements
Software as a Medical Device (SaMD) presents complex challenges – especially when navigating different regulatory frameworks across the UK, Australia, and New Zealand. We help you create region-specific documentation, ensure Medical Device Software Compliance with IEC standards, and meet local authority expectations for a smooth approval process.
Your Challenges
How We Help
- Classification & Regulatory Strategy
We help you determine the correct Medical Device Software Classification and define the optimal approval pathway for UKCA, TGA, or Medsafe. - Region-specific Documentation Support
Our templates, guidance, and reviews are tailored for UKCA, TGA, and Medsafe expectations. - Compliance with IEC 62304, 62366-1 & Cybersecurity
We help you meet essential requirements for software safety, usability, and data security. - Full Technical File Creation or Review
From CBOMs to validation protocols – we build audit-ready submissions that regulators approve.
What Our MDR Technical Documentation Support Covers
SaMD Technical File Assembly
Build compliant software documentation aligned with IEC 62304 and your target region.
Cybersecurity Documentation
Develop threat models, CBOMs, and mitigation plans aligned with MDCG and TGA expectations.
Validation & Traceability
Document software testing, verification & validation in a format accepted by MHRA, TGA, and Medsafe.
Usability Engineering
Apply IEC 62366-1 and document user interface safety per local authority requirements.
Local Regulatory Alignment
Adjust language, structure, and content for UKCA, TGA, or Medsafe-specific submissions.
Collaboration with QA/RA Teams
We integrate seamlessly with your team or external consultants – no micromanagement needed.
