Clinical Evaluation Reports (CERs) document the assessment and analysis of clinical data (literature, results of clinical investigations, complaints) and preclinical data to establish conformity of a medical device with the pertinent requirements of the Medical Devices Directive.

Recent publication of ISO 14155:2011 introduces new requirements that supplement the requirements and recommendations for CERs that appear in MEDDEV 2.7.1 Rev 3 and GHTF document SG5/N2R8:2007.

This audio conference presentation outlines these new requirements and provides helpful hints and examples of how to meet, efficiently and effectively, new and existing CER requirements.

This audio conference covers:

• When Clinical Evaluation Reports (CERs) are required
• Which standards and regulations apply
• What information to include
• How to limit literature searches to retrieve the most relevant articles
• How to further select the most relevant publications from retrieved articles
• What regulators look for when examining CERs
• How to leverage information in CERs for other regulatory and product development purposes

About the speaker:

Phil Triolo PhD, RAC is president of Phil Triolo and Associates LC, founded in Salt Lake City in 1996. He helps companies develop medical devices and combination products that meet pre-market US and international regulatory requirements, ensuring rapid approvals and market introductions.

Phil has authored over 20 CERs which have been accepted by most of the well-known Notified Bodies, including BSI, KEMA, TUV Product Services, NSAI, and DNV. His technical specialty areas are implants, cardiovascular and vascular access devices, and combination products, with an emphasis on biocompatibility and medical device antimicrobial coatings and surface modifications.

Phil received his BS in biomedical engineering from Rensselaer Polytechnic Institute and Masters and PhD in bioengineering from the University of Utah. He is an AIMBE fellow, past chairperson of the Biomaterials Availability and Policy special interest group of the Society for Biomaterials, and is currently Regulatory Affairs editor for SurFACTS, (the newsletter of the Surfaces in Biomaterials Foundation) and an adjunct assistant professor in the Department of Bioengineering at the University of Utah.

Who should attend?

• Clinical Operations
• Regulatory Affairs
• Quality Control/Assurance