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Medical Device Software Development Management:Following FDA Guidelines for Software Validation

Cover

Developing software for medical devices that complies with the FDA's Quality System regulation is a
challenging endeavor that's as much a business issue as it is an engineering feat.

Read this white paper to discover:

  • Software development challenges that medical device makers face
  • Why the FDA recommends a software development lifecycle (SDLC) approach that integrates risk management strategies with principles for software validation
  • And tips for putting the FDA's recommended approach into action.
Vendor:
Parasoft Corporation
Posted:
05 Feb 2013
Published:
31 Dec 2012
Format:
PDF
Length:
10 Page(s)
Type:
White Paper
Language:
English

This resource is no longer available.