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Our head of Regulatory Ed Drower was just recently interviewed on the Easy Medical Device Podcast to discuss MDR Literature Search best practices and other research topics.
Latest Publications
Look here for Industry updates and technical tutorials written by the CiteMed staff. All things Medical Device Regulation are covered in our publications.
Are You Over Committing to Your EU MDR Post Market Surveillance Plan?
Overview The EU MDR and IVDR will usher in increased post-market surveillance (PMS) requirements for all MedTech companies. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why [...]
Classifying Software as Medical Device in EU MDR
Introduction to Software as a Medical Device in MDR The MDCG’s Guidance document defines the criteria for software qualification falling within the scope of the EU MDR and IVDR. This doc even seeks to [...]
How to Hire a Literature Search (or CER) Writer and What to Look For?
INTRODUCTION A literature search is a deliberate and efficient search from already distributed information to distinguish between a good quality reference on a particular topic. There are different reasons for conducting a literature search, [...]
UK details a Post-Brexit Medical Device Regime Starting January
With ongoing negotiations over a trade deal between the UK and the EU and less than 30 days until the end of the Brexit transition period, the UK Government continues to flesh out guidance [...]
Post-Brexit Medical Device Regulatory Compliance – UK MHRA Guidance
What the Medicines and Healthcare products Regulatory Agency does MHRA is an executive agency in the Department of Health and Social Care. The Medicine and Healthcare products Regulatory Agency regulates medicines and devices for [...]
Your NB’s Clinical Evaluation Assessment Report
What is a clinical evaluation report? Clinical Evaluation Reports are a must for all medical devices in Europe. They must submit your CER to your Notified Body as an attachment to your European CE [...]