Contact Integer Holdings in Quakertown

Address:    Phone: Certification:
2000 Am Dr P
Quakertown,
PA 18951
USA
   267-733-0200

FDA Registered Facility
(Registration: 2532027)

Compliant to ISO 19227
(Implantable Device Cleaning Standard)

Compliant to ISO 14001
(Environmental Management System)

ISO 9001:2015, AS9100D and ISO 13485:2016 accredited facility


Our Locations

 

Integer > North America > Quakertown

Quakertown West, Pennsylvania

     Site capabilities include:

Operational Excellence:

  • Proven track record of high-quality precision machining with state-of-the-art Swiss machining, milling, laser machining (cutting, welding, etching, surface modification) and EDM capabilities.
  • Commitment to quality and compliance, supported by a robust state-of-the-art metrology department with the capability to achieve measurements as precise as 1 micron, and backed by certifications in key industry standards.
  • Efficient production processes enhanced by semi-automation and cobot technology, ensuring consistent quality and reduced lead times.
  • Extensive secondary operations: electropolishing, passivation, blasting, anodization, tumbling, buffing, deburring.
  • A comprehensive suite of manufacturing services from machining to sub-assembly, coupled with in-house finishing processes like electropolishing and coating, offers customers a single-source solution, streamlining their supply chain and reducing complexity.

Technology Innovation:

  • Proprietary surface texturing and coating technologies like Hierarchical Surface Restructuring (HSR™) and Titanium Nitride (TiN) coatings offer unique solutions for enhanced product performance.
  • Expertise in handling a wide range of materials, including precious metals, base metals, and advanced plastics, enabling the development of specialized components for diverse applications.

Engineering Services:

  • Concept Development
    • 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
  • Prototyping
    • Convert your idea to a real part on machines that are qualified for commercialized production
    • Reduce development time from prototypes to production
  • Testing & Characterization
    • Reduce lead time by weeks by completing manufacturing and testing under one roof
    • ASTM, ISO Industry standards for testing and characterization
  • Verification & Validation
    • Follow ISO standards to perform V&V builds and testing
    • Process Map, Sustainability, Kaizen, Recordkeeping
    • “Quality in everything we do”
  • Documentation
    • 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
  • Mfg. Process Development & Production Transfer
    • Prepare PTI site for commercialized production
    • Transfer process and train OEM site employees
    • Transfer process and train competitor site employees
  • Quality and Compliance:
    • FDA Registered Facility (Registration: 2532027)
    • Compliant to ISO 19227 (Implantable Device Cleaning Standard)
    • Compliant to ISO 14001 (Environmental Management System)
    • ISO 9001:2015, AS9100D and ISO 13485:2016 accredited facility


Integer Careers in Quakertown

We offer careers that shape the future of healthcare
and enhance people's lives.
Learn more!