Expert Regulatory Support for Medical Devices and IVDs

From Market Entry to Post-Market Success

Partner with regulatory specialists, trusted by global HealthTech

Clinical Evaluation services for medical devices by SciMed Consultancy – expert regulatory support for clinical evaluation, equivalence strategy, ongoing clinical maintenance for EU MDR, UK MDR and international compliance.

Ensure your clinical evidence stands up to scrutiny. From robust literature search methodologies to CER execution and remediation, we deliver compliant, audit-ready documentation.

Post-Market Surveillance (PMS) and Post-Market SClinical Follow-up (PMCF) documentation for medical devices by SciMed Consultancy – supporting proactive data collection, risk management, and EU/UK MDR compliance.

Proactively meet EU MDR Article 61 and annex XIV Part 8, MHRA and other, international requirements with robust PMCF and PMS strategies.

What We Do

We help medical device and in vitro diagnostic (IVD) companies navigate complex regulatory requirements across all device classes—from routine products to high-risk medical devices, companion diagnostics, and medical device software compliance.

From early-stage concept to final regulatory submissions, we help ensure your evidence meets the requirements of Notified Bodies and competent authorities.

Whether you're managing a broad portfolio and need scalable, portfolio-wide regulatory support, or you're spinning out breakthrough science from a university or hospital setting and need tailored start-up regulatory support, we know what regulators want—and how to build the regulatory evidence that secures CE marking and long-term market success.

Medical device and IVD regulations are tightening globally. Europe's MDR and IVDR now require comprehensive clinical evidence, performance evaluation, and post-market surveillance for both new and legacy devices. Clinical Evaluation Plans, Performance Evaluation Plans, and PMCF are now mandatory.

The UK MDR 2002 is diverging from EU rules, creating regulatory compliance challenges. Meanwhile, FDA regulatory expectations emphasize safety, effectiveness, and real-world evidence for high-risk medical devices.

Companies need tailored regulatory strategies for each market to ensure successful market access while meeting these evolving regulatory drivers.

  • Accelerate market access

  • Mitigate regulatory risks

  • Enhance post-market readiness

  • Minimise costly compliance delays

Let’s Simplify Regulatory Complexity