Medical Device Reliability Program

Chet Haibel
Chet Haibel has been in New Product Development all his professional life. His first 18 years were spent "learning by doing" as an R&D Engineer, Project Leader, and Program Manager on a wide variety of products at three different divisions of Hewlett-Packard Company, and at a start-up company.As Reliability Engineering Manager of Disk Drives at Hewlett-Packard, Chet was instrumental in more


The FDA has their Design Controls in the Code of Federal Regulations Title 21 Part 820.30, then for outside the US, we have ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes, and finally there is ISO 14971 Medical devices -- Application of risk management to medical devices. How can the New Product Development (NPD) process make conforming to these standards into an advantage and accomplish the appropriate Reliability activities in their proper place and sequence to avoid those expensive "loopbacks" (which are really NPD rework)? Can a NPD project steer clear of situations requiring compromise in Reliability to avoid repeating clinical trials or to preserve the project schedule? Can a company avoid recalls for Reliability issues by knowing what the Reliability will be before product release? An optimal New Product Development process will be presented that successfully deals with these challenges.

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