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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.
Literature Reviews Under The In Vitro Diagnostic Regulation (IVDR)
Literature reviews are an essential part of the clinical evaluation process for medical devices. The clinical evaluation report assesses a medical device's benefit-risk profile to ensure its continued safety, efficiency, and compliance. Most regulatory [...]
In Vitro Diagnostic Device Regulation (IVDR)
The In Vitro Diagnostic Regulation has held the center of the medical device manufacturers' community's attention for a while now. While most manufacturers know of it, many details can still be confusing. Here are the [...]
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 it different from post-market surveillance? And why is vigilance a separate entity [...]
10 Tips about Feedback from Clients and Users for Medical Device Manufacturers
Feedback is important. No matter what you're selling, if you want to improve, it's crucial to know what customers think of your product and how they feel about the experience they have with it. [...]
Five Practical Tips for Writing a Compliant Clinical Evaluation Report (CER)
Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations and guidelines change, as does the attitude of the notified bodies. A [...]
12 EU MDR Guidance Documents You Need
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With the slow but steady transfer of MDD to MDR, various aspects of requirements [...]