Design, Prototyping and Engineering 

Meet Your New R&D Resource

Pulse’s engineering team has been at the forefront of medical device manufacturing for 25 years. From developing Advanced Technologies to delivering expert guidance, we act as an extension of your R&D team to provide you with the best prices, lead times and quality.

INTEGRATION

Vertically integrated with post-process capabilities

Industry leading in-house metrology and testing capabilities

CAPACITY

70,000 sq. ft. purpose-built facility

Access to more than 100 manufacturing CNC machine tools

LEAD TIME

Iterative, client-led process: design, test, repeat on-site

Data formatted to go to DHF/DHR

Implementation

One of the few contract manufacturers to offer process transfers to OEM or competitor sites

Experience

25 years of medical device manufacturing experience

Capabilities

CONCEPT DEVELOPMENT

Listen, Understand, Propose

  • Review your design ideas and layer the functional requirements of the medical device and suggest modifications
  • Collaborate on cross-functional DFM projects
  • Work on risk mitigation and PFMEA projects on designs that are solidified to identify future pitfalls

PROTOTYPES

See, Try, Change

  • Convert your idea to a real part on machines that are qualified for commercialized production
  • Reduce development time from prototypes to production

TESTING & CHARACTERIZATION

See, Try, Change

  • Reduce lead time by weeks by completing manufacturing and testing under one roof
  • ASTM, ISO Industry standards for testing and characterization

VERIFICATION & VALIDATION

Qualify, Verify, Validate

  • Follow ISO standards to perform V&V builds and testing
  • Process Map, Poka-Yoke, Kaizen, Recordkeeping
  • “Quality in everything we do”

DOCUMENTATION

Record, Process, Update

  • Procedure write-ups from process observance
  • Modify existing or dated records to match current requirements
  • Help Process/Site transfers by documenting all variables that impact a start-up

MANUFACTURING PROCESS DEVELOPMENT & PRODUCTION TRANSFER

Design, Develop, Deploy

  • Prepare PTI site for commercialized production
  • Transfer process and train OEM site employees
  • Transfer process and train competitor site employees

Contact us to get a quote.

© 2021 Pulse Technologies, Inc. All rights reserved.