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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.
Post Market Surveillance Series – Part 2 and Vigilance Reporting
Part 2: Vigilance and Incident Reporting In the second post of our Post Market Surveillance series we’re going to dive into incident reporting and vigilance. This section of MDR deals with how your firm [...]
Post Market Surveillance Series – Part 1
Post Market Surveillance in MDR There are only a handful of explicit things that you HAVE to do under MDR for PMS, however there are a lot more things you SHOULD be doing to [...]
MDR Date Of Application: Should You Certify Now?
MDR Date Of Application Is Approaching Introduction The May 2020 deadline outline in Reg 2017/745 is a cutoff for new filings under MDD, the previous regulation. If your product is [...]
Periodic Safety Update Reports: Why You Might Need One Annually
Periodic Safety Update Reports: Why You Might Need One Did you know that the Literature Searches you submit for your CE Marking Clinical Evaluation Report might have to be re-run annually? [...]
Cost Savings of Literature Searches in Your CER
Cost Savings of Literature Searches in Your CER Introduction We recently had a client that wanted to weigh the option of outsourcing their entire CER project overseas to more attractively [...]
Medical Device Regulations – Links You Should Be Aware Of
Medical Device Regulations – Links You Should Be Aware Of Overview These are the most important regulations to be aware of governing Medical Devices in the European Union. If you [...]