(0 Item)

Verification and Validation (V&V) of Software in the Medical Devices

Webinars - Verification and Validation (V&V) of Software in the Medical Devices
Webinars

By : Compliance Online

Date : 2012

Location : California / Palo Alto

Video 01h 16m
Description :

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.

Keywords :

Medical Device Software, Software V&V, Verification, Validation, FDA requirements , Verification Methods

Product/ documentation details
Verification and Validation (V&V) of Software in the Medical Devices

Product Type : On Demand Webinar

Author : Dev Raheja

Video 01h 16m

Languages : English


Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device. Usually multiple factors affect the device performance. Therefore right validation is the key to prevent device recalls.

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.

 

 

Areas Covered in the Seminar:

  • FDA Quality System Requirements for software.
  • FDA guidelines on Software Verification and Validation.
  • Smart software verification methods.
  • How to design smart validation tests.
  • How to conduct Black box testing and white box testing to perform thorough validation.
  • How to conduct diabolic tests and wicked tests to avoid product recalls.

 

Dev Raheja, a respected and sought out expert on medical device and hospital care safety, draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and system reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. 

Verification and Validation (V&V) of Software in the Medical Devices

Product Type : On Demand Webinar

Author : Dev Raheja

Video 01h 16m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria