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EU MDR 6 min read

Medical Device Regulations – Links You Should Be Aware Of

Medical device regulations are no joke. It's pretty important to get the regulations right, since even a single missed data, if significant…

By CiteMed Author

20 Nov 2025

Vigilance 6 min read

Vigilance Reporting Under the MDR: Insider’s Guide

Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

The Top 5 Regulatory Requirements for the Medical Device Industry

Being in the regulatory industry is not as cut and dry as most people think. Sure, you do have to read a…

By CiteMed Author

20 Nov 2025

EU MDR 5 min read

Unexpected Documents You Might Need for Your Clinical Evaluation Report

Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat,…

By CiteMed Author

20 Nov 2025

PMS and PMCF 7 min read

Building Your PMS Templates

This document intends to cover a comprehensive framework for each of your products. Use it as a guide to direct your staff…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Your MDR Readiness Checklist

The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation…

By CiteMed Author

20 Nov 2025

IVDR 7 min read

In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges

All medical devices have their merit since all of them are used in the medical field. However, the In vitro diagnostic tools…

By CiteMed Author

20 Nov 2025

PMS and PMCF 6 min read

Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?

Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes…

By CiteMed Author

20 Nov 2025