Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of your medical device company? How do you know if it is or isn't? If it is wrong-sized, what can you do to correct it? Today’s guest, Mike Drues of Vascular Sciences, and I discuss this topic through the lenses of regulatory and quality factors to share with listeners the best ways to approach and succeed in right-sizing your QMS. Some of the highlights of the show include: ● QMS: Policies and procedures in place to meet regulatory requirements and define design, development, manufacturing, and servicing of medical devices. ● Two Extremes: Company’s QMS is too light because of vague and ambiguous verbiage, or too weighted with burdensome specifics; neither of which is a right-sized QMS. ● Company Pulse: To effectively right-size your QMS, you must understand who your company is, where you are, what stage you’re at in the process, and who’s involved. ● Perform a gap analysis, on-site visit, and internal audit to evaluate existing procedures and adjust as necessary. ● Companies that don’t follow their own procedures create regulatory, quality, and product liability problems. ● If you can’t measure it, you can’t improve it: Achieve consistent, repeatable, and reproducible outcomes. ● The difference between compliance and true quality, and why it’s important: Improve quality of life and provide the best possible outcome for patients. ● Are rules meant to be broken? Don’t follow rules blindly, especially if they don’t make sense. Be practical and pragmatic.