Medical Device Vigilance - Reporting Requirements in the EU

is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, January 12th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

The revised MEDDEV 2.12-1 Rev 6 guidance about medical device vigilance came into effect in December of 2009. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.

In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?

Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.

Medical Device Vigilance - Reporting Requirements in the EU

is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Tuesday, October 26th, 2010. For more details or to register, please visit our site at www.fxconferences.com

The revised MEDDEV 2.12-1 Rev 5 guidance about medical device vigilance came into effect on January 1, 2008. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.

In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?

Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.

Medical Device Vigilance in the EU: Reporting Requirements & Event Trending

The revised MEDDEV 2.12-1 Rev 5 guidance regarding medical device vigilance was issued in April 2007, and came into effect on January 1, 2008. Whilst not legally binding, this guidance does reflect EU competent authority expectations, and companies are advised to build their vigilance system around the guidance, which needs to be fully understood. For example, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). Examination of the patient reveals movement in the joint, demonstrating lack of fusion. Is this a reportable event?

In this session the speaker reviews the guidance, explains some key definitions and responsibilities, provides a vigilance process map and examines the criteria for reporting, using several examples. Event trending is also discussed, and how to make sense of the information that is delivered via the vigilance system.

Medical Device Vigilance in the EU: Reporting Requirements & Event Trending is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Tuesday, September 22, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Medical Device Vigilance: An Input to Risk Management

Risk management is the process by which medical device manufacturers ensure that their devices are used with the minimum of risk. The risk management process involves assessing all theoretical, potential and actual risks for a product (the inputs), assessing the impact of those risks on the user of the device, and putting in place strategies to mitigate those risks (the outputs). Early in the device development process, most of the risks are theoretical. However, as the device moves into clinical use, safety data are generated and real risks are identified or confirmed.

This audio conference presents information about how vigilance (the collection and appraisal of human safety information), supplemented by non-clinical and bench data, feeds into the risk management process, and how the outputs are managed. This sounds like a fairly simple process, but interpreting vigilance data is not always easy. There may be internal corporate resistance to ideal modes of risk mitigation, and it is difficult to deal with risks that arise from misuse of the device. All of these issues are dealt with and illustrated by case studies presented in the audio conference.

Medical Device Vigilance: An Input to Risk Management is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Thursday, July 9, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com