SciMed’s
A free monthly digital magazine for Clinical, Regulatory & Quality teams: MDR/IVDR updates, Clinical Evaluation deep dives, PMCF & PMS guidance.
MedTech Horizon
Trusted by Leading MedTech Manufacturers
Written by Senior MedTech Regulatory Specialists
Built for in-house MedTech Regulatory Teams
In Every Issue:
MDR & IVR Change Radar (notified body trends & audit signals)
Clinical & Regulatory Strategy Breakdowns
Practical Checklists & Tools
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How to Build a Compliant PMS System
A compliant Post-Market Surveillance (PMS) system is not a reactive process. Under the EU Medical Device Regulation, it must proactively collect, analyse, and feed post-market data back into risk management, clinical evaluation, and corrective actions to demonstrate ongoing safety and performance throughout the device lifecycle.
UK PMS Regulations vs EU MDR
With the right updates, existing MDR-compliant systems can be efficiently adapted to meet the new MHRA requirements.