Clinical Evaluation Report Writing Training
If you are actively involved with the creation and maintenance of clinical evaluation files, our 2 day instructor-led training course will enhance your level of understanding on the application of key methods to ensure that the requirements of the new MDR are met.
Our expert tutors will give you the necessary skills to ensure all the requirements of the law are met and provide an insight into how the clinical evaluation is integrated with risk management, post-market surveillance, the periodic safety update report, the summary of safety and clinical performance, trending and the CAPA system.
Our team performs clinical evaluation reviews for notified bodies, allowing us to give you insights into the common pitfalls.
▪ Understand the additional requirements for clinical evaluation imposed by the MDR 2017/745
▪ Know how to address continuous updates of a clinical evaluation report in a practical way
▪ Understand where clinical evaluation fits in the legal framework
▪ Gain effective techniques for establishing that sufficient Information is presented in a CER
Unlike many other online trainings, we encourage you to bring and ask as many questions as you like! This is the best way to embed your knowledge and gain a thorough understanding.
We are here to help you make your medical devices compliant.
▪ Data analysis
▪ Data appraisal
▪ Data identification
▪ Regulation intentions
▪ Clinical investigations
▪ Post-Market Surveillance
This course is fully interactive and offers you the chance to take part in group activities, get your questions answered, participate in polls and share and download course materials.
Duration: 2 Days
Day 1: 8:30am - 16:30pm
Day 2: 9:00am - 16:30pm
Due to the nature of the course, an exact time of each topic can not be provided.
The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.
Who should attend?
This Clinical Evaluation training course has great value for anyone involved in implementing or maintain a clinical evaluation file.
▪ Quality Assurance professionals
▪ Quality Engineers
▪ Research and Design Engineers
▪ Internal Auditors
▪ Quality Managers
▪ Manufacturing Engineers
▪ Regulatory professionals
What will I receive?
▪ PDF training course notes, slides and handouts
▪ The opportunity to get your questions answered!
▪ Full tutor support
Don't just take our word for it - take a look at just a few of our virtual classroom attendee reviews!
Gwen Lawrence, ConvaTec Group
"I can't fault this CER course, the delivery was excellent, as was the content and especially the trainer Rod. He clearly knows his stuff and that's what makes all the difference. I only ticked prefer in-person training because sometimes it's good to get out of the office and do training in a different venue and I would rather meet the trainer in person. However this virtual training was the best I've ever done and I could find no fault whatsoever. I'd definitely recommend this course to colleagues."
Claire Stapleton, ConvaTec Group
"I really enjoyed the course, so many things finally clicked into place for me and I now feel much more confident in writing CER's. Worth every penny. Thank you so much!."
Lucy Welch, MediMark Scientific
"The course was great in confirming my current knowledge of Clinical Evaluation and expanding on this with the requirements for MDR. Rod was a great tutor full of knowledge, advice and enthusiasm for a subject which can be pretty dry!"
Ash Pallister, RB
"Thoroughly enjoyed the 2 day course! Rod was very insightful and knowledgeable, with a great grasp on the MDR. It was a great experience, that I would highly recommend to any medical professional."
Malene Landauro, Coloplast
"Rod was a great communicator and had set up a really good programme. You could feel his passion for the field and his vast hands-on experience. I would definitely recommend this course to anyone working with clinical evaluation"
Karen Ring, Linde
"Virtual training is a great option but it does depend on the subject, for this course it was ideal. I found the course was very informative and has given me a lot of assistance in planning how we move forward with clinical evaluation and ensuring ongoing compliance with the new regulations. Thank you"
Anglea Harrison, Sysmex
"The course was very comprehensive considering how large the topic is. I learnt a lot more than I expected to and the knowledge of the lecturer was excellent with a lot of hands on experience and advice."
Alan Barclay, Terumo BCT
"Fantastic to have an instructor with subject knowledge that was able to relate to the experience of participants. Presented and delivered at a good pace to allow understanding and ample opportunity for specific questions."