Commitment to Quality

Quality Works Here

Quality is our #1 priority because lives depend on us.

We design and manufacture components and finished devices that have a direct and positive impact on the lives of countless patients around the world. From our line workers to our design engineers, we hold ourselves to the highest standards of quality.

Our quality mantra is Quality Works Here. This summarizes our commitment to world-class quality in everything we do:

  • We take personal responsibility for quality
  • We monitor and continually improve our Quality Management System
  • We deliver customer-focused quality

Quality & Regulatory Compliance

With 50+ years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with FDA guidelines, at one of our ISO-certified facilities. We host 100+ audits per year from customers and regulatory bodies.

Our certifications and registrations:

  • ISO 13485 and 14971 Risk Management Certified
  • FDA Registered and compliant with the Quality System Regulation
  • Class I, II, and III medical devices, including Premarket Approval (PMA) products
  • Class 7 and Class 8 Cleanroom Controlled Environments
  • US FDA 21 CFR Part 820 compliance
  • Canadian Medical Device Conformity Assessment System compliance
  • ISO 9001 compliant quality system and registration

Global Quality Systems

Our enterprise-wide quality policy and program are designed to ensure consistent high quality and compliance at every location, on every project, at every stage of the product lifecycle. Dedicated on-site teams ensure compliance with rigorous internal quality systems, some of which include:

  • Supplier management
  • Internal audit processes
  • Validation strategy
  • Design controls
  • DHF-ready documentation
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