UK & EU MDR and IVDR Regulatory Support for Medical Devices & IVDs
For manufacturers who need audit-ready evidence, clearer regulatory strategy, and fewer compliance surprises.
Confidential. Leave with clear next steps.
1,000+Regulatory Submissions across the UK and EU
Reviewed by
over 20
Different Notified Bodies
10+ years
Supporting Clients Across Full Device Lifecycles
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"SciMed has been a trusted partner since day one. Their clinical evaluation expertise gave us confidence through multiple audits, and their reliability has made them an extension of our own team."
James Davis - Head of Quality and Regulatory; Caristo Diagnostics
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"They understood where we were and what we needed; no oversell, just solid work delivered with minimal fuss. It gave us confidence in our classification and next steps."
Miles Payling - Co-Founder; C the Signs
Services
Clinical Evaluation
Our Clinical Evaluation approach combines scientific rigour with practical regulatory insight. We guide you through MDR requirements step by step, ensuring your clinical evidence is robust, defensible, and regulator-ready.
SciMed’s MedTech Horizon: Three Resources to Help you Stay Audit-Ready
SciMed Consultancy Ltd partners with medical device and IVD companies across the globe to deliver clear, defensible regulatory solutions across the entire product lifecycle. Our expertise spans clinical evaluation, performance evaluation, post-market surveillance & maintenance and regulatory strategy; supporting compliant market access in the EU and UK.
Under MDR Annex XIV, the CEP is your anchor document. Define scope, map data, integrate risk and PMS, and show foresight. A robust CEP reassures notified bodies and builds a sustainable compliance framework for product safety and performance.