News & Events
Press Release: January 24, 2011 - Release of Software Validation Textbook
Current Events and Trends in Software Validation - MD&M Anaheim, February 10,2011
more details below ...
Intertech Exhibiting at BIOMEDevice Boston, April 6-7, 2011
Publications
New Textbook!
Medical Device Software: Verification, Validaton, and Compliance
by David A. Vogel, Ph.D. (Intertech founder and president)
Artech House Publishing - ISBN 978-1-59693-422-1
AAMI TIR36:2007 - Validation of Software for Regulated Processes
Announcements and Press Releases
MD&DI Magazine's "Notable 100" Names Intertech President David Vogel
David Vogel has the pleasure of chairing a session and presenting "Safety Assurance Cases and Medical Devices:" as part of a daylong session on Thursday, February 10, 2011 at the MD&M West Conference, held in Anaheim, California from February 7 through 10.
Other speakers in this session include:
John Murray - FDA - Medical Device Software Compliance Expert
Jeremy Jensen - Boston Scientific - CRM Compliance Consultant
Carl Wyrwa - Beckman Coulter - Director of Software Engineering
Beth Crandall - Boston Scientific - Manager Software Quality Assurance
The topics in this session are interesting and timely. Additional topics include "The Team Software Process and Personal Software Process", "Driving Laws, Regulations, Guidances, and Standards into Your Quality System", "Medical Device Software Compliance: Validation and Design Control", and "The Quality Assurance Role in Software Validation".
Safety Assurance Cases and Medical Devices
It´s been almost a year since the FDA made Safety Assurance Cases a topic in the Draft Guidance for Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions. Some of the first projects using this methodology are now at a stage that our early experience can be shared with attendees. Topics include:
- What Safety Assurance Cases are, and where the suggestion/requirement came from
- Why Safety Assurance Cases are desirable
- What Safety Assurance Cases look like
- Tips for organizing
- How much is enough
- Is there value in this methodology / documentation?
To learn more about all sessions, please visit the conference website or visit www.MDMWest.com to view the entire conference schedule.
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AAMI Webinar - October 8, 2008, 11 am EDT - Recorded Version Still Available
Validation of Software for Regulated Processes: An Overview of AAMI TIR36:2007
David Vogel of Intertech and John Murray of CDRH-FDA, both contributors to the Technical Information Report (TIR) will be co-presenting this webinar. The webinar will challenge the way medical device manufacturers think about validating regulated process software. Methods suggested in AAMI TIR36 discourage a checklist approach that is overly prescriptive. Instead, the TIR recommends an approach that emphasizes “critical thinking” and empowers those validating software to take innovative approaches to building confidence in the software for its intended use. The speakers will walk-though AAMI TIR36, introduce new validation concepts, and provide practical information on using the TIR to solve daily validation needs in a more value-added way.
If you were unable to attend the webinar live, you can purchase recorded versions from AAMI at http://www.aami.org/meetings/webinars/web.tir36/cd.form.pdf .
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Important Publications
AAMI TIR36:2007 Validation of Software for Regulated Processes
From AAMI's announcement of the TIR: "Throughout the life of software that is used to automate regulated processes — such as the design, manufacturing, and packaging of devices — appropriate controls must be in place to ensure that the software performs as intended.
To help manufacturers navigate this rugged terrain, AAMI has just published a new technical information report (TIR) called TIR36:2007, Validation of software for regulated processes, which offers guidance on appropriate software validation methods and tools."
David Vogel from Intertech was a member of the workgroup that developed this Technical Information Report. Dave has lectured and written about the work done in this work group for the last several years. You can order your copy of the TIR from AAMI at http://www.aami.org/applications/search/details.cfm?webid=P855_D4668
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Library
FDA Documents - FDA's Design Control Guidance was added. It's not a new release .. just inadvertently dropped when we redesigned the website.
New Additions to our Intertech Reprint Library
Eight new articles were added to our online library March 1, 2008 .
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Announcements and Press Releases
MD&DI Names Intertech President to
"100 Notable People in the Medical Device Industry"
In its June 2008 issue, MD&DI magazine named Intertech president, David Vogel, to its list of "100 Notable People in the Medical Device Industry. Quoting MD&DI :
"The medical device industry consists of products, processes, and technology. These are covered in almost every issue of MD&DI. But it also consists of people, without whom none of the amazing advances in medical science and technology would be possible.
In this issue, MD&DI honors some of the people who make these advances possible and who ensure that those devices can treat patients safely and effectively."
See the entire list at MD&DI's online version.
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