Regulatory Strategy for Software as a Medical Device (SaMD)

We support your SaMD or digital health product with end-to-end regulatory strategy, including:

• Classification and regulatory pathway planning

• CE Marking, UKCA, and FDA submissions (510(k), De Novo, PMA)

• Clinical Evaluation Reports (CERs), literature reviews, clinical evidence

• Software lifecycle documentation (IEC 62304, ISO 14971)

• Post-market surveillance and vigilance

We work with you to build a scalable regulatory foundation that accelerates approvals while reducing compliance risk.