June 13-14 2018

Lunch and Learn: Medical Device Software Verification and Validation

We invite you to join us for a Lunch and Learn presentation hosted by our own Darshit Makawana on how to verify and validate software for medical devices and regulations associated with it!

Software development is considerably more complex when the software is regulated as a medical device. The development and application of medical device software expands faster than can be managed by one federal agency. Although FDA relies on its own experience and expertise, input from other federal organizations, voluntary standards organizations and partnerships with industry has become a collaborative effort. At the same time, the device software industry needs to look beyond FDA itself to understand where FDA will eventually go in regulating software.

In this lunch and learn we will focus on following topics:
·       Regulations and Quality System
·       Software Life Cycle
·       Software Risk Management
·       Software Requirements
·       Software Design Controls
·       Tools and strategies to verify and validate.
·       Documentations needs for submissions

You will leave this event with key takeaways of how you can develop and execute software verification and validation plan for medical device.

Lunch and Learn Event Dates/Times:

Session 1: Wednesday June 13th 12:00pm – 1:00pm EST

Session 2: Thursday June 14th 12:00pm – 1:00 PST

If you would like to attend, please  contact Darshit Makawana (darshit.makawana@vaidation.org) with the session you will be attending.  We will send out a calendar invitation to the confirmed attendees.