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      A Snapshot of Coming Regulations: MDR – 14971:2019 – ISO 10993:2018 (ASQ Biomedical NCDG - Nov/Dec 2019 Roundtable) in Milpitas


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      November 13, 2019

      Wednesday   7:00 PM

      560 Cottonwood Drive
      Milpitas, California 95035

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      EVENT DETAILS
      A Snapshot of Coming Regulations: MDR – 14971:2019 – ISO 10993:2018 (ASQ Biomedical NCDG - Nov/Dec 2019 Roundtable)

      A Snapshot of Coming Regulations:MDR – 14971:2019 – ISO 10993:2018 Wednesday, November 13, 2019, 7:00 to 9:00 pm (This will be the final 2019 NCDG Roundtable: Date is the 2nd Wed. of November.) Topics: Are you prepared for the significant changes to European regulations? Several are coming, or evenclose to the enforcement period. Dan Griggs of BSI, Barry Craner, Former ASQ Biomedical DivisionChair, and Gregory Meyer of BioQ Pharma will share with us those changes and new requirements. Highlights of the MDR and transition thoughts A brief look at the coming 2019 update to the 14971 Risk standard A brief look at the 2018 updated version of the Biocompatibility Standard ISO 10993   Discussion: Participants are encouraged to share experiences with their transitions from the MDD toMDR, and feedback on the 10993:2018 changes and 14971 expected changes. Featured Speakers:   Dan Griggs: Dan has a Masters in Regulatory Affairs Science, and is Accounts Manager – BusinessDevelopment in the San Francisco Bay-area and greater Northern California of BSI Group America Inc. Danrepresents a team of more than 200 global experts in medical technology, and he has organized and ledmany working groups to EU essential requirements. Barry Craner: Barry has two masters (cardiac physiology and an MBA in Computer Information Systems),with an EE minor and is an ASQ Fellow. He was Vice President of Stellartech Research Corporation for 5years just before retiring, and now consults in device risk management. He also retired from more than 12years teaching at two California University Graduate programs (UC and as Professor CSUDH MSQAprogram). Gregory Meyer: Greg is currently VP of Quality and Regulatory at BioQ Pharma Inc., a maker of single-usepre-loaded drug infusion pumps for parenteral medications. He is the founder of Compliance Media, a BayArea company providing quality and compliance consulting, training, and auditing, and is the producer ofFDA: A History, an FDA sanctioned documentary film. He is an ASQ Certified Quality Auditor and is RACCertified by RAPs. Moderator:   Geetha Rao is a well known and seasoned medical device consultant, on several tandardscommittees and a trusted resource for the Northern California Biomedical Discussion Group. Location: Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035  Food:  Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.  Email: To be added to or removed from our email list, contact George Marcel, gjmarcel@gmail.com.    Registration Link: http://ncdgnov2019.eventbrite.com/     ONLY Check or Credit Card accepted at door Questions: For information about this session, contact Shreya Chandrasekhar (shreya.chandrasekhar@gmail.com). Formal discussion and questions will end between 7:45 - 8:00 pm to allow time for networking. Materials: Presentation & workshop sheets provided. Please limit distribution to attendees: personal professional use only. Webinar Remote Access (no cost):  https://attendee.gotowebinar.com/register/3020807443755054604

      Categories: Science

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