counts for 0.5 recertification units (RU)

Topics:

Are you prepared for the significant changes to European regulations? Several are coming, or even
close to the enforcement period. Dan Griggs of BSI, Barry Craner, Former ASQ Biomedical Division
Chair, 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 to
MDR, 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 – Business
Development in the San Francisco Bay-area and greater Northern California of BSI Group America Inc. Dan
represents a team of more than 200 global experts in medical technology, and he has organized and led
many 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 5
years just before retiring, and now consults in device risk management. He also retired from more than 12
years teaching at two California University Graduate programs (UC and as Professor CSUDH MSQA
program).

Gregory Meyer: Greg is currently VP of Quality and Regulatory at BioQ Pharma Inc., a maker of single-use
pre-loaded drug infusion pumps for parenteral medications. He is the founder of Compliance Media, a Bay
Area company providing quality and compliance consulting, training, and auditing, and is the producer of
FDA: A History, an FDA sanctioned documentary film. He is an ASQ Certified Quality Auditor and is RAC
Certified by RAPs.

Moderator:

Geetha Rao is a well known and seasoned medical device consultant, on several tandards
committees 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