The ISO 14155 standard was revised earlier this year and has been introduced in many countries as the standard to support the conduct of medical device clinical investigations. This audio conference presentation provides an in-depth review of the standard, and discusses how it should be implemented and utilized to conduct medical device studies.

In addition, our speaker goes beyond just looking at the standard, and provides attendees with guidance and insight on how to conduct a medical device clinical investigation – what documents to produce, what details to provide, and how to set up, manage, monitor and complete a medical device clinical investigation.

This audio conference covers:

• The provisions and recent revisions to the ISO 14155 standard
• How to conduct medical device studies in accordance with ISO 14155
• Understanding your responsibilities as either Sponsor or Investigator
• Adverse event reporting requirements for medical device clinical investigations in Europe

About the speaker:

Janette Benaddi, RGN, BSc, MICR, CSci, CDir is the CEO of Medvance Ltd, providing clinical research and regulatory consulting services to the medical device and healthcare industries. She has over 24 years of experience managing pre- and post-market clinical studies in both devices and pharmaceuticals. Prior to founding Medvance 12 years ago, she worked in Paris for a medical device consultancy group as Project Director in Clinical/Regulatory Affairs. Janette has also worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products.

Janette is a registered nurse, has a BSc in Management Studies, a Diploma in Company Direction, a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. She is the Chair of the Board of Directors at The Institute of Clinical Research in the UK and is also currently Chairman of the Knowledge Transfer Network Clinical Studies Special Interest Group. Janette has published several articles and sits on a number of committees involved in the regulation and standardization of medical device studies.

Who should attend?

• Clinical Research Associates
• Clinical Coordinators
• Clinical Project Leaders
• Senior CRAs
• Monitors
• Researchers