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.

This audio conference covers:

• Vigilance system definitions and goals
• Important definitions and responsibilities
• Criteria for reporting (using examples)
• Vigilance process maps
• Reporting timelines
• Trends

About the speaker:

Helen Colquhoun is CEO of Pleiad Inc, a full-service medical device CRO. She has worked in the medical device and pharmaceutical industries for more than 20 years. She is a physician with a depth of experience in vigilance, pharmacovigilance, regulatory affairs, clinical study design and management, and product development planning. Her expertise covers North America and Europe. She is based in Cambridge, Massachusetts.

Who should attend?

• Regulatory Affairs
• Quality Managers
• Safety Managers
• Design Engineers
• Sales and Marketing