Medical Device Contract Manufacturing ♦ Medical Device Product Design & Development

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

Medical Device Product Development

Concept Development, Prototyping, Design Verification, and Scale-Up to Validated Manufacturing

Phase 2 assists medical device companies through all stages of the product development process.  We utilize our ISO 13485 registered 4 stage development process  to guide activities resulting in successful product launches.  Phase 2 has tremendous experience with U.S. FDA Class I, II, and III medical devices with the majority of the products design and built being complex surgical instruments that are terminally sterilized.


Phase 2 Product Development






 Activities that Phase 2 supports during different the different stages of the product development process includes:

  • Rapid Prototyping / 3-D Printing
  • Part design including design for manufacturability
  • Process Design
  • Fixture Development including Gage R&R
  • Test Method Development
  • Design Verification Builds and Testing
  • Packaging Validation protocols, execution, and testing
  • Sterilization Validation protocols, execution, and testing
  • Manufacturing Validation Builds
  • Transfer to manufacturing


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