Presentations

CMMI and Medical Device Software Engineering - Presentation

2009 November ASQ International Conference on Software Quality

 

Applying Quality Principles to Software - Presentation

2009 January ASQ Section 1003 Meeting

 

Software Excellence Through Process Excellence - Presentation 

2008 Great Lakes Software Excellence Conference

 

Convincing Executives to Invest - Presentation

2008 Workshop on Technical Debt

     Medical Device Software Articles

New IEC 80001: Application of Risk Management for IT-Networks Incorporating Medical Devices - FDA News

Published in May 2009 ASQ Software Division Newsletter

 

New IEC 80002: Application of ISO 14971 to Software - FDA News

Published in Feb 2009 ASQ Software Division Newsletter

 

Another Look at GPSV - FDA News 

Published in JUL 2006 ASQ Software Division Newsletter

 

FDA 483's, Where the Rubber Hits the Road - FDA News

Published in APR 2006 ASQ Software Division Newsletter

 

Good Medical Device Software Links - FDA News

Published in JAN 2006 ASQ Software Division Newsletter

 

Petition to Revoke Part 11 - FDA News

Published in NOV 2004 ASQ Software Division Newsletter

 

Risk Management For Medical Device Software - FDA News

Published in SEP 2004 ASQ Software Division Newsletter

 

     CMMI^® Articles and Papers

What It Means to be CMMI Level 2 or 3 - Short Summary 

 

Comparing the CMMI-DEV to Medical Device Regulations and Guidance - White Paper and Mapping Tables

 

CMMI - 20 Strategies for Small Teams- 20 Strategies

 

CMMI - Barriers and Advantages for Small Teams                                  - Barriers & Advantages

 

CMMI - General Hints for Success - General Hints

 

Process Improvement, Environmental Parameters- Parameters

 

     David Walker's Resume

Resume in PDF Format

Resume in MS Word format

 

Additional Details

See the CMMI here SEI 

Copies of IEC 62304 can be ordered here AAMI

CSQE Body of Knowledge (BOK) public access here ASQ

Need More Information?

Send an email to Dave