Headlines from Medical Device SIG Meeting 13th May 2008
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Plans are being made for a Medical Devices Forum on ‘Hot Topics’ prior to further developments on an Intermediate training Course and e-learning
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The MDSIG poster at 2008 Spring Conference was well received
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Members of MDSIG have provided feedback on the UKCRN costing model for budgeting for Clinical Trials
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May 2008 CRFocus contains article on 10 things you need to know about medical devices
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Check out the NRES website for Medical Device application guidance
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mCTA for Medical Devices is nearing completion and should be available later this year
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There are plans for a Medical Device specific CRFocus at the end of the year
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Note the deadline of end 2008 to apply for Chartered Scientist designation via ICR
Headlines from 7th March 2008 meeting
Medical Device Introductory Course
The introductory course for medical device professionals will run again on 3 December this year. The speakers will be Keith Summerhayes Director of clinical and regulatory affairs at Ranier Technologies and Kath Clarke Regulatory Affairs Manager at Tissue Science Laboratories. Both speakers are extremely experienced in regulatory and clinical affairs. To register for the event ……..
Special Device Issue of CRF
The November issue of CRF Focus will be dedicated to the device industry. The sub committee are currently preparing articles if you are interested in writing for this issue please contact Andrew Smith at ICR
Medical Devices Speed Networking at this years ICR Conference
A medical devices speed networking session will be held on Tuesday 8 April at the ICR conference. If you are attending the conference please come along to this event. This will be a great opportunity to meet with colleagues and other professionals working within the device industry. For more information please contact Michelle Noble.
NRES Device Guidance
NRES Guidance for applying for Research ethics committee approval for device studies will be finalised in the next two weeks and will be available on the NRES website. The document is extremely useful in explaining the process for applying for device research approval and the types of device studies that exist.
mCIA
The model clinical investigation agreement is progressing. The Department of Health and ABHI are currently involved in progressing the document. Should you require more information on this document please contact ABHI.
Poster Presentation at ICR Meeting
A poster will be presented by Olive Murphy – Clinical Project Manger at Crescent Diagnostic on the impact and implications of the amendments to the directive on medical device clinical research.
Amended Medical Device Directive
A consolidated version of the amended directive is available for download from http://ec.europa.eu/enterprise/medical_devices/guide-stds-directives/cons_vers_93-42-eec.pdf
MHRA Adverse Event Reporting DataBase.
The new databse for reporting adverse device events “MORE II” is now available on the MHRA website.
