News & Events
Press Release: January 24, 2011 - Release of Software Validation Textbook
Announcements and Press Releases
MD&DI Magazine's "Notable 100" Names Intertech President David Vogel
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.
Trade Shows & AAMI Workshops:
BIOMEDevice Boston Trade Show (An MD&M Event) - April 13-14, 2016
Venue: Boston Convention & Exhibition Center, Boston, MA
Intertech will be exhibiting in Booth 408
AAMI Workshop: Developing and Validating Software for the Medical Device Industry:
October 14 - 16, 2015, Venue: Renaissance Las Vegas Hotel, Las Vegas, NV.
Dave Vogel is the Lead Instructor.
Course details at http://www.aami.org/events/eventdetail.aspx?ItemNumber=1891.
AAMI Workshop: Developing and Validating Software for the Medical Device Industry
It´s been over a year since the FDA made Safety Assurance Cases a topic in the Draft Guidance for Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions.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.
AAMI Webinar Available on CD: 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) co-presented this webinar on October 8, 2008. The webinar challenged 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. David and John walk you 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.
To purchase this Webinar CD from AAMI go to www.aami.org.
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
The book can be ordered from:
- Artech House Publishing (select location, then add to cart)
- Barnes & Noble
- Matthews Medical Books
- Login Brothers Canada
Or order directly from us. Orders direct from us are shipped on the next business day (assuming in stock), and are sent by USPS Media Mail. Bulk purchase, international orders, or expedited shipping call 781-801-1100.
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 www.aami.org
FDA Documents - FDA's Design Control Guidance