Stay up-to-date on Medical Device Clinical Trials http://www.clinicaldevice.com en-us https://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed https://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed FDA held a public meeting on 18 February 2010 to discuss issues and actions that can be taken to revise, improve, and strengthen the 510(k) process. If you missed it, you should obtain the audio recording, transcript, and slides from Clinical Device Group. Read more... https://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed https://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed The 2007 amendment to the European Medical Device Directive comes into force in March 2010, and it requires a clinical evaluation report (CE Report) be conducted as part of the process to market a device. Since Notified Bodies (NB) will review the results of the evaluation, it is important that the clinical evaluation is conducted correctly and robustly. Take this e-conference and learn what are the NB expectations for these reports. Read more... http://clinicaldevice.typepad.com/cdg_e_conferences/design-control-of-investigational-devices-complaints-to-be-monitorable-under-iso-14155-2010-.html http://clinicaldevice.typepad.com/cdg_e_conferences/design-control-of-investigational-devices-complaints-to-be-monitorable-under-iso-14155-2010-.html The new ISO 14155 "Clinical investigation of medical devices in human subjects - good clinical practices" will be published in 2010. It is likely to be recognized by FDA, which will give it tremendous standing within the US, as well as EU and Japan. The standard will alter the foundation of every clinical trial conducted. It makes the need for investigational device design control paramount and its deficiency monitorable and reportable within the adverse event reporting system. Read more... https://www.clinicaldevice.com/mall/Workshops.aspx?source=rssfeed https://www.clinicaldevice.com/mall/Workshops.aspx?source=rssfeed This five-hour workshop will cover why and how to implement a registry study. Read more... https://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed https://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed You are probably already aware of the new requirements for Clinical Evaluation Reports if you sell medical devices in Europe. Coming into force in 2010, every medical device--including Class I and Class IIa- -will be required to have a Clinical Evaluation Report in its technical file. The Global Harmonization Task Force guidance explains how to do a clinical evaluation that will conform to the new MDD standards. Take this e-conference, and see how to conduct a step-by- step clinical evaluation according to the GHTF guidance. Read more... https://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed https://www.clinicaldevice.com/mall/eConferenceCD.aspx?source=rssfeed As part of our ongoing series on "Understanding ISO 14155 (2010)", CDG is proud to invite Wessam Sonbol of Clinical Systems Consultants Inc to discuss the elements of good data management for medical device trials utilizing paper-based case report forms. Read more... http://www.clinicaldevice.com/09-15-09_Email_ISO14155.htm?source=rssfeed http://www.clinicaldevice.com/09-15-09_Email_ISO14155.htm?source=rssfeed The international standard for medical device clinical research is about to undergo sweeping changes. The first and most evident change is the change in title; the standard is now known as ISO/DIS 14155 Clinical Investigations of Medical Devices in Human Subjects--GOOD CLINICAL PRACTICES. Read more... http://www.clinicaldevice.com/09-09-14_Clinical_Evaluation_Report_Whitepaper.htm?source=rssfeed http://www.clinicaldevice.com/09-09-14_Clinical_Evaluation_Report_Whitepaper.htm?source=rssfeed You are probably already aware of the new requirements for Clinical Evaluation Reports if you sell medical devices in Europe. Coming into force in 2010, every medical device--including Class I and Class IIa- -will be required to have a Clinical Evaluation Report in it's technical file. Read more... https://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed https://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed The CRA Handbook is the fieldguide for monitoring medical device clinical trials. It contains full text copies of US regulations, a detailed comparison of requirements for significant risk and non-significant risk studies, guidelines, checklists, definitions and flowcharts from the ISO 14155 Parts 1 and 2, and definitions and flowcharts for adverse event management. https://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed https://www.clinicaldevice.com/mall/ProductPage.aspx?source=rssfeed It is complicated to keep it straight in your head, but easy with the pocket-sized, laminated, FDA and ISO consistent Adverse Event Wheel. This easy AE look-up tool takes you or your study coordinators to uniform first-cut categorizations of adverse events so they are reported on time, just as defined in your protocol. http://www.clinicaldevice.com/training/09-11-06_OnDemandSpecial.htm?source=rssfeed http://www.clinicaldevice.com/training/09-11-06_OnDemandSpecial.htm?source=rssfeed Our high-level workshops and e-conferences are available OnDemand so you can view the presentations on your schedule, when you need them. OnDemand workshops and e-conferencesalso provide the opportunity to earn continuing education credits/contact hours (CEUs) at your convenience.