Quality / Regulatory

SPEC Engineering Co. is ISO 13485 certified by BSI. We are registered with the FDA, registration  # 2031913.

Our Quality Control Department is fully equipped with Zeiss CMM machines and optical comparators for the inspection of all parts that are manufactured and assembled by SPEC Engineering Company.

We maintain a comprehensive Quality Assurance System throughout the complete production cycle.  SPEC Engineering employs strategic tools to assist in risk management assessment, such as;

  • Validation – Equipment installation qualification, Operation qualification, and Process qualification procedures.
  • PFMEA – Process Failure Modes Analysis.
  • SPC – Statistical Process Control.
  • Design for Manufacturing        


  • SPEC Engineering delivers products of the highest quality and service to our Customers.
  • Our Manufacturing Engineering staff can provide assistance from the design stage to include con-current engineering and prototyping for product manufacturability offering potential for cost and production lead time reduction.
  • To support quick-turn product development for prototyping and production, we design and manufacture all fixtures “in-house” that are required for machining.