OUR SERVICES

SEEING SUCCESS

When you are successful, we are successful.  We are prepared to hit the ground running on your project by providing top-notch, experienced Medical Device Professionals.  We are able to quickly learn about your project needs and make a difference by using engineering expertise along with thorough knowledge of regulations and expert writing ability to fill in the gaps. 

Irwin Consultants have expertise in the following areas:

Quality Engineering

Quality Assurance

Manufacturing Engineering

Project Management

Sterilization / Biocompatibility

Verification / Validation

Process Development

Technical Writing

Software Validation

R&D

Regulatory

Quality Systems

Design Control

© 2017 by Irwin & Associates, Inc.