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    • Capabilities
      • Prototyping
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      • About Us
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  • Home
  • Capabilities
    • Prototyping
    • Design and Development
    • GMP Manufacturing
    • Cleanroom Manufacturing
  • Projects
  • News
    • Blog
    • Press Releases
    • Events
  • About Us
    • About Us
    • Our Team
    • Quality
  • Contact Us
  • We're Hiring!

Quality

Quality

Quality is the backbone of medical device development and manufacturing

Design and Development

Formal ISO 13485 design and development process is used consisting of 8 phases:  Requirements, Risk Analysis, Detail Design, Verification, Engineering Release, Clinical/Regulatory, Design Transfer, and Sustaining support.

Manufacturing

ISO 13485 compliant manufacturing including purchasing, receiving, receiving inspection, lot traceability, kitting, work instructions, in process testing, CNC machining, polymer component production, box build, packaging and shipping. 

Environmental Control

Environmental controls include ESD protection, relative humidity, ISO cleanroom particulate and microbial, sterile air supply, ultrapure nitrogen supply, RO water, ionizing air gun (inside and outside cleanroom), incubators and temperature chambers.

ISO 13485 Certificate

DesignPlex 13485 MD 724622 (pdf)Download

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