Mantra Systems - Medical Device Regulatory Consulting Services UK
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An archive of our publicly available videos discussing the the medical deivce regulatory environment
Video 14: CER (Clinical Evaluation Report) Clinic
Video 13: 5 useful resources for writing a medical device Clinical Evaluation Report (CER)
Video 12: What you need to know about the importance of medical device document management systems
Video 11: Five common pitfalls when writing a Clinical Evaluation Report
Video 10: Our Clinical Evaluation Service including CERs & CEPs
Video 9: An in-depth look into medical device equivalence and its role in device approval under the MDR
Video 8: What is Post-Market Surveillance (PMS) in the EU MDR?
Video 7: Choosing the right Clinical Evaluation Report template
Video 6: What is MDR Compliance?
Video 5: How to build a winning strategy for EU MDR Compliance & Medical Device Regulatory requirements
Video 4: MDR Gap Analyser Tool - Helps perform Gap Analysis on medical devices
Video 3: Using a Clinical Evaluation Report template to write EU MDR-compliant CERs
Video 2: How to work with Annex VIII of the MDR
Video 1: How to work with Annex I of the EU MDR
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