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Look here for Industry updates and technical tutorials written by the CiteMed staff. All things Medical Device Regulation are covered in our publications.
Literature Reviews for EU MDR
Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is essential to the clinical evaluation process for medical devices. The clinical evaluation [...]
How to Find The Best CER Medical Writers & Strategy
Are you shopping for CER writers? Or perhaps trying to evaluate if this is the type of document you can make work yourself? Then this article is for you. With the transition to [...]
CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of technology to medical devices. While medical testing devices, scans, and robotic surgical [...]
Vigilance Reporting Under the MDR: Insider’s Guide
Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market surveillance and vigilance system requirements for medical device manufacturers compared to previous regulations. [...]
The UK MDR and The EU MDR: What Are The Differences?
UK MDR is the primary standard that mandates requirements for anyone selling medical products in the UK, as it is a vast market that often goes unexplored. After the UK left European Union, there [...]
Top Regulatory Updates in 2022: New Documents, Regulatory Scandals, and Useful Information
2022 was quite the year. While the pandemic slowly fizzled, medical device companies and medical writers enjoyed new guidelines and regulations, first-row seats to the biggest recall in FDA history, and a bunch of odd [...]