Fixed-fee, fixed-scope AI Compliance Assessment for manufacturers of AI-enabled medical devices and IVDs. £4,950 + VAT covers a structured review across seven assessment dimensions, including regulatory positioning, governance, validation, human oversight, technical documentation readiness, post-market monitoring, and change control.

You'll receive a written assessment report, gap and risk summary, prioritised action roadmap, and a 30-minute executive briefing with a SciMed consultant. Findings are delivered within 10 working days of receiving the required documentation.

The assessment is designed for manufacturers developing AI-enabled products, preparing technical documentation, assessing AI-related regulatory obligations, or reviewing existing products already on the market against evolving governance expectations.

Reserving here skips the scoping call. After payment, we'll be in touch to confirm document requirements, agree document sharing under NDA, and schedule the assessment. The 10-working-day delivery period begins once all requested documentation has been received.