Turning Complex Medical Data Into Engaging Reader-Friendly Stories
Turning Complex Medical Data into Engaging, Reader-Friendly Stories How to Transform Evidence into Clear, Actionable and Trustworthy Medical Narratives By Dr. Alyssa…
12 Dec 2025
EU Clinical Trial Regulation: What you Need to Know
For manufacturers, clinical trials or at least the protocol are already planned and set to go for up to 2023. However, a…
20 Nov 2025
The Post-Market Surveillance Document: Which Ones Do you Need?
Under EU MDR, PMS documentation comes down to four core documents: a PMS plan for every device (Article 84), a PMCF plan…
20 Nov 2025
Meddev 2.7 1 Rev 4: Guidelines for Literature Search
MEDDEV 2.7.1 Rev. 4 remains the most important technical guidance document for conducting literature searches within the European medical device regulatory framework.…
20 Nov 2025
ISO Standards for Medical Devices: What they are and When you Need Them
The whole point of medical devices is to improve patient safety and patient quality of life. That's it, that's the gist. To…
20 Nov 2025
Self-Certification for CE Mark – An Overview
The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in…
20 Nov 2025
Medical Device Reporting (MDR): How to Report Problems to the FDA
Even though every medical device manufacturer does their utmost to ensure their medical devices are safe and efficient, adverse events still happen.…
20 Nov 2025
The DIY Clinical Evaluation Report – Do You Really Need A CER Writer?
So you’ve taken a look at EU MDR transitions for some of your devices and shopped around for quotes on help writing…
20 Nov 2025