PROJECTS

We have expertise as individual contributors and Project Managers throughout the Medical Device life-cycle.  Some of our most recent projects include:
  • Design Control Project Management for Software Launch

  • Specification Documents and Requirement Tracing

  • Quality Engineering Support for Improved Device Reliability and Lower Complaints

  • Verification / Validation of New Equipment

  • Process Development and Parameter Establishment

  • Product Transfers:  R&D to Production

  • R&D Project Management

  • Technical Writing for Complex Systems

  • Develop and Establish Quality Systems

  • Risk Management

  • Auditing

  • Human Factors

  • Biocompatability / Environmental Monitoring

© 2017 by Irwin & Associates, Inc.