Compliance services for ISO and
FDA regulations since 1994

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Call Tim Stein at 1-408-768-7538

BPA plays a national leadership role in education on software regulatory compliance and quality systems.

Publications by R. Timothy Stein, Ph.D.

Stein, R. Timothy, The Computer System Risk Management and Validation Life Cycle, Paton Press. 2006. 600 pages.

Stein, R. Timothy, "Avoiding Software Meltdown," Quality Digest, March 2005

Recent Presentations by R. Timothy Stein, Ph.D.

Tim has made over 40 public presentations over the past decade on software regulatory compliance, as well as on quality standards/regulations (e.g., ISO 13485, ISO 14971, QSRs, and ISO 9001). Here are some of the highlights.

Achieving Compliance with IEC 62304 for the Development of Medical Device Software, Northern California Biomedical Discussion Group, July 24, 2013

Mobile Medical Applications - Software regulatory requirements, with Bill Kurani, Compliance Online Webinar, 90 minutes, April 16, 2013

Achieving Medical Device Software Compliance under IEC 62304, IEEE webinar, May 24, 2012

Outsourcing Medical Device Software Development with Compliance to IEC 62304, ComplianceOnline, Webinar, 3 hours, November 2, 2011

Management of Software Sub-suppliers, Presentation as part of the seminar "IEC 62304 Development and Validation of Medical Software." San Jose, October 28, 2011

Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304), Compliance Online Webinar, 3 hours, June 14, 2011.

Verification in the Development of Medical Device Software per IEC 62304. International Conference on Software Quality 2011, February 9, 2011.

Achieving Compliance during Computer System Validation: A Risk-Based Approach, 2010 RAPS national Annual Conference & Exhibition, 24-27 October 2010, San Jose

Meeting the New MDD Requirements for Medical Device Software Development - IEC 62304, Silicon Valley ASQ Quality Conference 2010 - The Road to Innovation in Quality!, 21-22, October 2010

How to Apply Critical Thinking to a Variety of Validation Scenarios: Spreadsheets, Access Applications, Web Hosted Software, and Purchased Applications, Institute of Validation Technology's 11th Annual Computer and Software Validation conference, April 21-23, 2010 in San Diego

Risk Analysis Methods and Tools for Software Validation, Institute of Validation Technology's 11th Annual Computer and Software Validation conference, April 21-23, 2010 in San Diego

Risk Analysis Methods and Tools for Software Validation and Infrastructure Qualification, two and a half hour pre-conference workshop at the 13th IT Infrastructure Compliance, Security and Risk Management for Regulated Industries. International Quality and Productivity Center conference, November 16, 2009, Philadelphia.

Reducing the Pain and Increasing Your Return from Defining Requirements. Institute of Validation Technology, Fall Conference, San Francisco, October 2008

Practical Change Control in a Regulated Environment. Institute of Validation Technology, Fall Conference, San Francisco, October 2008

Using a Risk-Based Process for the Validation of Applications to Save Time and Money, 10th IT Infrastructure Qualification and Application Validation for Pharmaceuticals. October 22, 2007.

Validating Computer Systems for Business Applications,Full Day Seminar presented in Bangalore, India, December 2006.

Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements. ComplianceOnline, FDA Compliance Webinar Series, March 8, 2006.

Review of the Part 11 Regulations and a Discussion of Issues, Presented to the American Society for Quality, Software Task Group for the Silicon Valley Section, November 9, 2004.

What's New in ISO13485 and How to Deal with It, Presentation made to the San Francisco Bay Area Biomedical Discussion Group, December 3, 2003.