About
ISO 13485 with Design 2016. 21 CFR 820 compliant, FDA Validated. We are a manufacturer of medical device implants or provider of contract manufacturing services. We provide services in the design of medical devices for FDA 510(k) submissions. We apply a risk based approach to ensure the highest quality of our services.
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Keywords
medical device manufacturing
medical equipment manufacturing
cnc machining
medical equipment and supplies manufacturing
medical devices
precision manufacturing
pharma-grade cleaning
fda 510k devices
surface finishing
precision engineering
fda compliance
regulatory compliance
laser marking
product development
quality control
manufacturing
bespoke solutions
medical technology
material expertise
prototyping to full-scale production
ultrasonic cleaning
consulting
b2b
healthcare
advanced manufacturing technologies
prototyping
quality control systems
medical components
wire edm
fda registered
Company Information
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Employees 5
Location
2967 Waterview Dr, Rochester, Michigan, United States, 48309-4600