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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.
IVDR Part II – Your Technical Documentation and Performance Evaluation
What will the new EU regulations mean for in vitro diagnostics? In 2022 the long-running IVDD will be replaced by another system called IVDR, thus inaugurating a new era for the regulations of InV. [...]
EU IVDR – Part I
The EU IVDR Regulation - An Overview - Part I The PIP breast implant scandal brought to light weaknesses in the overall regulatory process to control IVDs. It may include - The certification [...]
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation shall be May 26, 2020. Formed today, introducing the new regulations means [...]
The Delay of EU MDR
The EU MDR Delay – What It Means For Your Medical Devices With the global COVID-19 pandemic disrupting industries, medical device stakeholders have rapidly diverted efforts from the short-term urgency of ensuring regulatory compliance [...]
EU MDR Clinical Evaluation Requirements – Understanding the CER
EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity assessment process is that clinical evaluation reports are essential to selling or [...]
How Your Notified Body Is Grading Your EU MDR CER
MDCG's Guidance document, released in July 2020, introduces and details the essential requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its [...]