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 [...]
Post-market Clinical Follow-up (PMCF): What you Need and How to Get It
One of the new aspects introduced in the European Medical Device Regulation 2017/745 (MDR) is [...]
Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR
Under the European Medical Device Regulation (EU MDR 2017/745), manufacturers are required to conduct [...]
Building Your PMS Templates
This document intends to cover a comprehensive framework for each of your products. Use [...]
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 [...]
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by the [...]
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, [...]
Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to ensure [...]
Post Market Surveillance EU MDR – CiteMed
Post-market surveillance (PMS) under the EU MDR (2017/745) is a systematic and proactive process [...]