MindFlow Design, a leading product developer for medical, life sciences and consumer health companies, has earned ISO 9001:2015 certification for having high-quality management systems that meet a highly respected international standard.
Certification by the International Organization for Standardization followed a third-party audit of MindFlow Design’s abilities to focus on customers, continuously improve, provide effective leadership, design and management product development, engage people and make evidence-based decisions in accordance with a recognized process.
“We now have additional evidence to present to clients that our processes, products and procedures are world class,” said MindFlow Design Principal Chris Ross.
Based in Southern California, MindFlow Design becomes one of 30,000 companies around the nation to have achieved the ISO 9001 designation and also one of the first 52 to meet the latest revised version of it.
A related ISO 13485 certification exists specific to medical device development and it too has recently been revised. MindFlow Design had intended to pursue both certifications simultaneously, but is deferring the ISO 13485 effort for a few more months until auditors become available to provide certificates relating to the updated designation.
In preparation for meeting both the ISO 9001 and 13485 standards, MindFlow introduced its proprietary GuideWay™ Design and Development Process that “aligns with federal FDA guidelines for the design and development of medical products,” Ross said.
Maintaining each standard will require continuing audits at three-year intervals.