Medical devices
- Electrical safety to the IEC/AS 60601-1 series, including collateral and particular standards, and EMC to IEC/AS 60601-1-2
- TGA conformity assessment evidence and ARTG inclusion support
- Essential principles mapping and technical file structuring
- Parallel pathways: EU MDR and IVDR, UK MHRA, and FDA where relevant
Medical work rewards structure. Most delays we see are documentation gaps, not test failures — an essential principles matrix that does not trace to evidence, or a risk file that has not kept up with design changes.
