Get regulatory
approval

Regulatory strategy

Understand how to navigate Software as a Medical Device (SaMD),  draft your intended use statement and understand your risk classification.

Map regulatory pathways for Software as a Medical Device (SaMD) across priority markets: in the US, define the regulatory route (e.g., FDA 510(k) or De Novo), classification, and submission plan; in the UK, prepare for MHRA UKCA marking; and in the EU, align with MDR requirements

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).