Right-sizing your QMS - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2019-11-07T15:06:52
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.
Further episodes of Global Medical Device Podcast powered by Greenlight Guru
Further podcasts by Greenlight Guru's Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers