Device Research Workshop 2013

Registration Fees:

SoCRA member - $675 - non-member - $750

Non-member fee includes membership for one year.

Preconference Workshop Fee: $175

Goal: This DEVICE RESEARCH conference for Clinical Research Professionals will introduce, explain and discuss concepts and current issues relating to compliance, research development and clinical investigation in the current regulatory environment. Those new to device research may also elect to participate in the half-day DEVICE BASICS workshop which will be held the afternoon prior to the main 2-day program.

Objective: This 2-day advanced conference will include experts involved in the research and development of safe and effective medical devices. Day 1 includes a 510(k) Update, PMA Submission Strategy a PMA Case Study from FDA experts as well as speakers discussing Evaluating Effectiveness, FDA Perspective on IVD, IRB Roles and Responsibilities and ISO 14155. Day 2 will include presentations from innovation, communication and human factors experts. Presenters will also discuss process methods to integrate clinical trials into your design process, review risk management for devices, device monitoring and reporting device-related adverse events and effects.

Learning Objectives: Pre-Conference Workshop

The participant will be able to:

-Discuss the regulations that govern the administration of device research including risk categorization and device classifications

-Discuss site selection, study monitoring and management

-Discuss fundamental CDRH BIMO IRB inspections

-Review the basic concepts related to medical device research

Learning Objectives: Conference

The participant will be able to:

-Discuss issues related to the conduct of device clinical research

-Describe 510(k) changes to existing 510