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Genesis is registered with the FDA and is ISO 13485 compliant. We have a full time QC department hosting a CMM. Our QC inspector performs full in-house 1st article qualification and 100% inspection after completing each process, before sending product to our clients. Our facility uses only approved material suppliers and outside process vendors for heat treating and plating if required.

About Us

Genesis Design & Fabrication, LLC is a full service, U.S. based Specialty Surgical Instrument facility …

  • Genesis was established in 2002 and has built a reputation with the medical community as the “go-to” resource for quality, quick turnaround specialty instruments.

  •      Genesis offers start to finish solutions to fulfill the demanding surgeon’s custom instrument needs.  We have 20+ years of instrument design experience and have completed multiple projects for some of the largest orthopedics companies.  Our 3D design capabilities provide unique visual and technical clarity that can evolve our client’s ideas into a computer viewable 3D model.  We work closely with the surgeons, engineers and implant manufacturers to produce a design that will help the surgeons achieve their desired results.  Instruments produced at Genesis range from simple existing instrument modifications, to completely new instruments designed to our client’s specifications.

  •       Validated fabrication services offered in-house are: CNC machining, EDM, TIG and Laser welding as well as Laser Marking.

Quality Statement 

It is the goal of Genesis Design & Fabrication to maintain our excellent reputation as a supplier in the medical device industry by providing quality products and services which meet our customer's current and future expectations.

Quality is therefore essential and fundamental to our continuous success. We recognize that this quality will be achieved by:

  • a TOTAL QUALITY MANAGEMENT approach where every EMPLOYEE, SUPPLIER and CUSTOMER are essential components

  • an ERROR-FREE performance standard based on PREVENTION and RIGHT FIRST TIME attitude

  • implementing our quality system in compliance with ISO & FDA STANDARDS and relevant International SAFETY REGULATORY Requirements

  • development of all PERSONNEL through TRAINING at all levels of our operations.

  • The objective and expectation is for our customers to have full confidence in Genesis. Their satisfaction is fundamental to our long term development. This will come from the efforts of each employee in conjunction with supportive participation from management. Therefore Genesis management and staff are committed to the above philosophy and directives.

Our Customers:

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