Quality

A Progressive Quality Leader

Quality has been an integral part of our Mission since co-founder Earl Bakken penned it in 1960. One of the six tenets of our Mission is:

To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.

With lives at stake, we take our responsibility for quality very seriously. To us, that means:

  • Approaching quality holistically – not just with products, but in everything we do (see visual below)
  • Having comprehensive, closed-loop processes across the entire product lifecycle
  • Being proactive – to prevent and uncover issues early
  • Being collaborative – working with physicians who are closest to our products and processes
  • Being transparent – sharing our expectations and performance and with all our stakeholders, and raising awareness of potential issues early

Our Quality Policy

We will exceed our customers' expectations by striving without reserve, for unsurpassed product quality, reliability, and patient safety through effective, agile, and compliant processes.

We are committed to maintain and continually improve the effectiveness of our quality management systems, comply with all applicable requirements, and deliver excellence to customers through our products, processes, services, and relationships.