Clinical Data Evaluation for Medical Devices

VIRTUAL CLASSROOMS

Gwen Lawrence

"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

"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

"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

"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." 

Alan Barclay

"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." 

Course Overview

 

If you are actively involved with the creation and maintenance of clinical evaluation files, our two day real-time 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 virtual courses allow you to join our expert tutors and fellow delegates together on a web based classroom where you can fully engage in group activities, ask questions and share materials as if you were in a real classroom. All you need to be able to attend is access to a microphone and Google Chrome. 

Course Content

▪    PMCF 

▪    Planning

▪    Data analysis 

▪    Data appraisal 

▪    Data identification 

▪    Regulation intentions 

▪    Clinical investigations 

▪    Post-Market Surveillance 

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

▪    PDF Clinical Evaluation training course certificate 

▪    Full tutor support and access during course times

Our software will allow you to:

▪    Raise your 'virtual' hand to ask questions

▪    Participate in polls and surveys and see results

▪    Undertake exercises on your own or in a group

▪    Download and share materials and documents 

▪    Chat online with the facilitators and other delegates 

View our other training options →

Address

Meddev Solutions Ltd

River House, Home Avenue 

Newry BT34 2DL

Email: info@meddevsolutions.co.uk

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