Medical Devices Track
This track is Chaired by Leo Eisner of Eisner Safety Consultants. The track is supported by Global Advantage International.
The Medical Devices Trackl provides medical device design safety training. Issues to be discussed include IEC 60601-1, 3rd ed., CB scheme related to IEC 60601-1, 3rd ed, ISO 13485:2003, human factors, reliability, risk management, design controls, safety and effectiveness, standards, regulatory requirements.
Who Should Attend
- Product Safety Engineers
- R&D Engineers & Managers
- Product Managers
- QA/RA Engineers & Managers
- Compliance & Reliability Engineers
- Complaint Evaluators
- Technical & Regulatory Consultants
- Technical Marketing
Attending this focussed program will help fulfil a portion of the training requirements under the approved Quality System (21CFR820.25), MDD, CMDR, etc., ISO 13485 (6.2.1 & 6.2.2) in your organization.
Presentation Schedule - Tuesday, 27-Oct-09 - Ballroom IV
The presentation schedule is preliminary and subject to change without notice.
| Time | Topic | Speaker |
| 8:00 | Ensuring Safety and Efficacy through ISO 14971 |
Alf Dolan |
| 9:00 | Industry Update: Where do we Stand with IEC60601-1 3rd ED | Leo Eisner |
| 10:00 | Break/Exhibits OPEN - Ballroom III |
|
| 10:30 | Certification Options for the 3rd Ed - CBTL Perspective | Andrew Saunders |
| 11:30 | Lunch/Exhibits OPEN - Ballroom III | |
| 1:00 | ISO13486:2003 & CMDCAS requirements for Medical Devices in Canada | Randy Martin |
| 2:00 | Relationship of Reliability to Medical Device Safety and Effectiveness | Sandy Weineger |
| 3:00 | Break/Exhibits OPEN - Ballroom III | |
| 3:30 | An Integrative Approach to Medical Device Safety: Human-Centered Systems Engineering |
George Samaras |
| 4:30 | Panel Discussion |
Moderator: Panelists: |
