Get regulatory
approval

Regulatory strategy

Map regulatory pathways for Software as a Medical Device (SaMD),  draft your intended use statement and understand your risk classification.

Regulatory submission

Document the clinical evidence of your SaMD (clinical evaluation plans and reports) and prepare your regulatory submission in the UK, EU and US (including compliance with IEC 62304, IEC 62366-1, and IEC 82304).

Cybersecurity and data privacy

Achieve compliance with cybersecurity and privacy requirements for digital health solutions (including compliance with IEC 81001-5-1).

Quality management system (QMS)

Get support to build and implement a QMS to meet ISO standards (e.g., ISO 13485).