Michelle Potvin

Director, QA/RA , Swan Valley Medical

Michelle Potvin is a Quality expert with 20+ years of medical device quality assurance experience managing technical product details through supplier quality engineering and validations. A hands-on leader with 10+ years in developing and implementing quality management systems for small to mid-sized companies. She is an American Society for Quality Certified Quality Auditor, and a member of the ASQ Leadership Team. Michelle lives with her husband, daughter and two German Shepherds in Colorado.

Session Track:

Tuesday, May 16 2:50 PM - 3:20 PM 208

PL1445B - Breeze Through FDA and ISO Audits With Confidence

Medical device manufacturers around the globe must comply with regulations. Government entities, like the FDA in the US, have the power to close a business temporarily or permanently based on audit or inspection results. The goal is to maximize patient safety. Because the stakes are so high, audits and inspections can be very stressful. Managing product and quality information in one system is a source of confidence for quality management. In this session, we’ll discuss using Arena QMS to comply with the US FDA 21 CFR Part 820 and the ISO 9000 series. 21 CFR Part 920 outlines requirements for medical device manufacturers. The ISO 9000 series helps companies in any industry effectively document the system elements needed to maintain an efficient quality system.

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