Artwork for podcast Global Medical Device Podcast powered by Greenlight Guru
How to Ensure Your Quality Management System is Effective and Benefits Patients
Episode 607th November 2019 • Global Medical Device Podcast powered by Greenlight Guru • Greenlight Guru + Medical Device Entrepreneurs
00:00:00 00:35:21

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When it comes to quality management compliance, would you consider yourself a box checker or a true quality professional? On today’s episode, we talk with Mike Drues, president of Vascular Sciences, about what it means to be a true quality professional and how to ensure your quality management system is effective and benefits patients. Do you want to offer medical devices that improve your patients’ quality of life? Don’t wait until an FDA audit to make changes or try and fix problems. Some of the highlights of the show include: ● Data does not lie and medical device companies are not doing enough. ● The number of warning letters issued by the FDA. ● Consent decrees are issued when companies keep doing the wrong thing or don’t take action. ● Reasons why companies receive 483s. ● Companies continue to make the same mistakes and not follow the rules. ● The value of training: What to learn and how to retain it. ● Measure the efficacy of your medical devices and training. ● Make sure your quality management system works and is effective by testing and validating it.




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