We can help you achieve ISO and FDA compliance by assessing your existing systems and developing new quality systems that address the gaps and work for your business.

  • ISO 13485
  • ISO 9001
  • 21 CFR 820


We are experts in the application of statistical Lean Six Sigma methods to achieve unprecedented process improvement.

Our consultants lead process verification and validation studies or design process characterization and optimizations studies to accelerate cycle time, eliminate waste, and reduce cost.


Our staff are experienced in both industry and consulting. We average more than 25 years work experience which translates into quicker results and increased client success.

We understand that our success is measured solely by your success. We work collaboratively to ensure transparency in our process and joint commitment to implementation.

Our Mission

Our mission is to help small to mid-sized manufacturing companies comply with quality, regulatory, and product standards. We do this by developing user-friendly quality management systems and by augmenting existing manufacturing processes with advanced manufacturing control systems.

We can help.

Give us a call and we will deliver the best service in the industry.

Talk to a Consultant