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EU MDR 6 min read

MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation

In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of…

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

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 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

EU MDR 9 min read

Software as a Medical Device (SaMD): EU MDR and FDA Regulatory Overview

Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Quality Management System: What ISO Standards Say About QMS

A quality management system is a huge part of producing medical devices. Whether you like the process or not, a well-designed and…

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