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Full SaMD Certification in just 6 Months. Guaranteed for any risk class. Our accelerated regulatory framework delivers full UKCA or CE-marking up to 12 months faster than standard. If we don't hit your timelines, we compensate you directly. Fastest ever route to market for digital health innovations over Class I. Limited to 4 companies per month - pre-approval required.

Full SaMD certification under UK or EU MDR up to 3x faster than standard. Your competitors are spending 18 months or more navigating MDR approval. We'll get you CE-marked in just 6 months - guaranteed. Secure first mover advantage and gain market share a full year ahead of the competition. Limited to 4 companies per month - see if you qualify (instant decision).

Get your SaMD certified 3x faster than standard. Normal EU MDR approval can take 18 months or more. For digital health innovators moving at pace, this timeline can be intolerable. We’ve developed a precision workflow that shaves a whole year off SaMD certification timelines. What's more: if you qualify, we'll guarantee it. No compromise - just compliance at the pace of innovation. Bring your SaMD to market 12 months before your competitors. Limited to 4 companies per month - apply now to see if you qualify.

Gain UKCA or CE-marking up to 3x faster than usual. Our Accelerated SaMD Compliance Programme carves 12+ months off standard MDR certification timelines. Unique MDR approval workflow with guaranteed completion dates for qualifying companies. Gain market share, hit investor milestones and boost your ROI. Limited to 4 companies per month - click now to find out more details.

Performance Evaluation is the most common failure point in IVDR submissions. Our expert team writes your PEP and PER to a standard guaranteed to meet EU IVDR requirements — a fully done-for-you service with unlimited support through to final Notified Body approval. To prove it, we'll write your Performance Evaluation Plan completely free of charge. See our quality for yourself before committing to anything. No risk. No obligation. Just expert IVDR support from day one. 👉 Contact our team — we'll do the rest.

Are you an IVD manufacturer seeking the fastest, most assured route to UK or EU approval? Our IVDR consulting services are built around your products — delivered by a team of clinicians, biomedical scientists, regulatory experts and professional medical writers who know exactly what Notified Bodies expect. From Performance Evaluation and technical file production to post-market follow-up, we cover the full scope of IVDR — with approval guaranteed. We'll even write your Performance Evaluation Plan completely free of charge. No risk, no obligation — just a chance to see our quality for yourself. 👉 Contact our team today and let's get started.