Medical Device Contract Manufacturing ♦ Medical Device Product Design & Development

  • Locations in Greater Boston & Tijuana, Mexico
  • +1 (603) 332-8900

Quality Systems

ISO 13485 and FDA Registered

Phase 2's Quality Management System (QMS) utilizes the APQP process to ensure quality is built in, while managing our client's overall cost requirements. 

Quality in a LEAN environment

One of the benefits of utilizing lean is that production lines can achieve "one-piece flow".  As a by-product of this, quality automatically improves due to operator focus on one product at a time.  Completion of quality inspection becomes an in-line requirement instead of a post manufacturing inspection. 

We monitor scrap and component rejects at the operation station and utilize floating quality inspectors to augment the walk path.  Our LEAN process focuses accountability for quality manufacturing on the operators.

Supplier Quality for components and consumables

Our incoming component inspection process is designed to minimize risk and waste while maximizing quality and throughput. We establish win-win partnerships with our suppliers as they are critical to our success and yours. We evaluate and monitor our suppliers through a scoring process that helps ensure all expectations are being met.

ISO Certifications & FDA Registered

Please click the links below to view our ISO certifications and/or request a copy of our ISO documents.



Product Development & Manufacturing
88 Airport Drive
Rochester, NH 03867

Phone Number
+1 (603) 332-8900

Mexico Manufacturing
Andador Vecinal No. 14301
Tijuana, BC CP22330

Phone Number
+1 (664) 231-3844