Sponsor or Organizer: NAMSA

Description: This seminar provides the most current information on preclinical and clinical testing required by regulatory bodies for market approval of medical devices and component materials.

Anyone involved in the design, development, or manufacture of medical devices will benefit from attending this seminar and workshop. NAMSA's Medical Device Development Process and Testing GuideT will be used to align test requirements with the phases of product development and create a framework for managing the process.

Participants will receive certificates of completion, reference materials, and the opportunity to interact with the seminar presenters, all of whom are experts in medical device testing.

Trends in Pre-Clinical Testing & Clinical Trials

Biocompatibility Testing

ISO 10993: Latest Developments

Materials Characterization

Regulatory Requirements for Conducting Clincal Trials

Considerations for Manufacturing & Sterilizing Devices

Sterilization Methods & Program Design

Packaging Validation

Dates: 03/23/2006

Location: Santa Clara, California, USA