CiteMed Evidence Cloud V6.0.6: Post Market Surveillance Software Release That Closes the Loop
Summary Altus, released in May 2026, made every stage of CiteMed Evidence Cloud faster. AI screening got a visible reasoning trail, PDF…
18 Aug 2026
The Post-Market Surveillance Document: Which Ones Do you Need?
It's not enough to make a device and put it on the market—you must know how people use your product. Therefore, the…
20 Nov 2025
PMCF Plan EU MDR: What You Need and How to Create It
Post-market clinical follow-up, or PMCF, is the proactive, ongoing collection of clinical data on a device after it reaches the EU market, used…
20 Nov 2025
Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR
The core PMCF templates, MDCG 2020-7 for the plan and MDCG 2020-8 for the evaluation report, are still current as of this…
20 Nov 2025
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…
20 Nov 2025
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…
20 Nov 2025
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
For medical devices specifically, the 2022 Blue Guide doesn't add much that MDR and IVDR don't already cover in more detail. It updated the market surveillance…
20 Nov 2025
PMCF for IVDR and MDR – A Case Study and How-To
By now, most of us have struggled through at least one successful submission for MDR/IVDR, and we know they take time. Very…
20 Nov 2025
Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed…
20 Nov 2025