Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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Webinar - Good Design Makes Regulatory Achievement Easier
Wednesday, February 10, 2021, 8:00 AM until 10:00 AM
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TOPIC: Product Design for clinical use requires understanding of user needs and regulatory requirements.
TOPIC DESCRIPTION: Maren Nelson https://www.linkedin.com/in/marenn and Scott Thielman Product Creation Studio https://www.productcreationstudio.com will discuss an overview of the challenges and opportunities of applying ISO13485:2016 in a design firm. They will discuss moving from idea to creation including the human factor analysis, design planning, and the risk analysis components of ISO 13485 with examples of products they assisted to develop
SPEAKERS: Scott Thielman and Maren Nelson, Product Creation Studio
Maren's goal is to help companies create affordable healthcare solutions that improve patient outcomes or prevent disease. She is an experienced professional in the development and regulatory approval of medical devices through the entire product life-cycle. Maren understands the regulatory requirements, and how to create compliant processes that add business value.
Her experience is in process improvement and training from R&D, business performance, and Quality perspectives. Maren's medical device experience includes external defibrillators and pacemakers, multi-parameter patient monitors, medical software, sterilizable accessories, ultrasound surgical devices, and electrical stimulation equipment.
Scott Thielman is CTO and co-founder of Product Creation Studio, a design driven engineering consultancy based in Seattle. With expertise leading the development of consumer, medical and industrial products, Scott has participated in all aspects of new product design and development for emerging and established global brands. Scott is an expert at combining cutting-edge technology with engaging, user-friendly design and has been instrumental in bringing numerous innovative products to market at Product Creation Studio.
Scott's leadership has helped client companies garner prestigious awards including the Red Dot Design Award, Good Design Award, I.D. Annual Design Review, Medical Design & Excellence Award (MDEA), and an MD&M West Innovation Prize. With over two decades of experience as an entrepreneur and product innovation expert, Scott is a recognized thought leader on topics ranging from AI and digital health to strategic product development and innovation best practices. He serves as a regular speaker for events produced by UBM, Xconomy, Frost & Sullivan, Life Science Washington, Association of Managers of Innovation, and more. He has also served as a juror for the Medical Design & Excellence Awards (MDEAs) and has authored articles for national publications including Medical Design & Outsourcing (MDO) and MD+DI. Scott is actively involved in the innovation community in Seattle and serves as the Life Science Committee Co-Chair for Keiretsu Forum's Northwest Chapter, the world's largest angel investor. He is involved in Seattle's Museum of History and Industry (MOHAI) as an innovation advisor and on the external advisory board for Engineering Innovation in Health (EIH) at the University of Washington. Scott holds a Ph.D. in mechanical engineering from the University of Washington and is a licensed professional engineer.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification