An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision. This audio conference focuses on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation reviews the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker also provides attendees with an essential clinical investigation document checklist.

This audio conference covers:

• Scope and status of the ISO 14155 revisions
• Alignment with evolving regulations governing clinical evaluation
• Standard harmonization and global acceptance by regulators
• ISO 14155 elements: human subject protection, ethics committee review, trial conduct responsibilities, clinical investigational plan, essential documents
• How ISO 14155 compares with FDA 21CFR 812 (Investigational Device Exemption)
• Integrating ISO 14155 with your quality system

About the speaker:

Carol Houts is the Director of Regulatory, Quality and Safety at Pleiad Inc, a full service medical device CRO. She has more than 14 years of experience in quality, regulatory affairs, compliance, auditing, data management systems, vigilance, post market surveillance, supplier management and regulatory compliance in both the medical device and pharmaceutical industries. Her regulatory expertise encompasses North America and European regulatory requirements, and she has supported both pilot and pivotal drug and device trials.

Who should attend?

• Regulatory Specialists / Managers
• Clinical Managers / Project Managers
• Clinical Research Coordinators / Associates
• Quality Assurance Managers / Associates
• Auditors
• Project Managers - Project Development