RegisterSaturday, February 09, 2021
 
FastTrak Med Device™
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Suite for Small to Medium Companies

FastTrak Med Device™ offered by Integware, is a powerful, user friendly and feature rich set of solutions that encompass key elements of 21 CFR part 820 and part 11 compliance:

  • Document Management
  • Change Control
  • Product Development Process (PDP)
  • Design History File (DHF)
  • Configuration Management / Device Master Record (DMR)
Integware’s FastTrak Med Device™ solution suite is:
  • Priced specifically for the small to medium-sized medical device company
  • Built on top of the proven, scalable, Matrix PLM Platform™
  • Delivered as a complete set of configuration services, validation scripts, online training and documentation
Benefits of FastTrak Med Device™
  • Accelerates new product launches
  • Reduces time-to-market
  • Reduces cost of compliance for 21 CFR part 820 and part 11
  • Reduces cost of quality (excess/rework/scrap)
  • Minimizes preparation for FDA audits 
  • Implements quickly - 6 weeks or less
  • Returns a rapid ROI - less than 12 months 
  • Integrates all processes seamlessly
  • Includes validation scripts, online training and documentation in its All In Delivery™
  • Employs industry proven processes