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Engineering & Quality Solutions, Inc., is your consulting firm for expert, timely service to support your medical device projects. We offer a wide range of experience and services with particular expertise in the orthopedics industry. Our clients range from surgeon entrepreneurs with a device idea, to start-ups to multi-million dollar companies with full product offerings. We provide the extra resources you need to complete your project on-time and under budget, from idea to launch projects or single design analysis and improvement projects and everything in between. Whether it's product development, design, analysis, manufacturing, design controls and 21 CFR 820 requirements, our consultants are committed to your success.

Trust Engineering & Quality Solutions for technical expertise, excellent client service and strict confidentiality. We understand the challenges of medical device engineering, development and product support. Our goal is to help you achieve yours.

NEWS

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If you're performing mechanical or performance testing on your devices, you may want to review this new FDA guidance to make sure that expected information is included in test reports and protocols intended for submissions. Presenting testing in the proper format will make the submission process faster and smoother.

See the link below for the guidance titled "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions":

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-non-clinical-bench-performance-testing-information-premarket

 

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Highlights of Products Experience

    Orthopedic Trauma Implants
  • Locking & Non-locking Plates
  • IM Nails & Lag Screws
  • Cortex & Cancellous Screws
  • Cannulated Screws
  • Locking Screws
    Orthopedic Instruments
  • Hand Tools
  • Drill Bits & Drill Guides
  • Wires
  • Spinal Surgery Instruments
    Spinal Devices
  • Pedicle Screws
  • Rods
  • Cervical & Lumbar Plates
  • Interbody Fusion Devices (IBFD)
  • PLIF, ALIF, TLIF, DLIF
  • Expandable Cages