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ASQ: MDR 2017 – A Honeycomb of Standards
April 12 @ 8:00 pm - 9:00 pm
Speaker – Marica Weeden – MDR 2017 – A Honeycomb of Standards
April 12, 2022 at 6PM PST
Registration Link: https://register.gotowebinar.com/register/325591103331550476
A frustrating development in the quality field is yet another regulation. At first glance, MDR 2017, the EU’s medical device regulation, can seem like the worst of the worst. Marcia Weeden discusses the evolution of standards and how MDR’s requirements are the epitome of a robust quality and risk management system utilizing the best of quality engineering tools.
Marcia M. Weeden’s quality career, writing expertise, and interest in history have made her a natural when it comes to identifying cause and effect and developing regulatory compliance documentation. In addition to strongly believing that regulatory documentation is a critical quality tool is very underrated, Ms. Weeden also believes that knowing how quality standards have evolved as technology advances is critical to appreciating the importance of regulatory documentation. Ms. Weeden has a MS in Textiles, Clothing, and Related Art with specializations in quality assurance and adult education from the University of Rhode Island. She has 18 years as an ASQ Certified Quality Engineer, is a Certified Quality Technician, and is the author of Failure Mode and Effects Analysis (FMEA) for Small Business Owners and Non-Engineers as well as multiple articles published by the ASQ. Ms. Weeden has been the Quality Assurance Director for two companies and is owner of Quality Excellence Services (QES,) a quality consulting firm specializing in quality and regulatory compliance. She has worked in Defense, medical devices, and pharmaceuticals.