ASQ New England Discussion Group (NEDG) Presents by request:
VIRTUAL WEBINAR: “QMS CURRENT REGULATORY REQUIREMENTS- Part 3”
Taming Complaints, Conducting Global Adverse Events Reporting, and Mastering CAPA Compliance
Are Your Quality Practices Aligned with Today’s Regulatory Expectations?
With evolving QSR, QMSR, and ISO 13485 standards, ensuring your systems are compliant is more critical than ever.
Join us for an in-depth “How to Comply” webinar designed to give you the practical knowledge and tools you need to stay fully compliant with current regulatory requirements.
-
Go beyond the typical (US, EU) - what does my company need for global AE reporting with Australia, Canada, China, Japan, Brazil, others?
To ensure your organization is audit-ready and aligned with the latest global quality expectations- Reserve your spot today and take control of compliance!
Timothy Barash - BSI Assessor, Retired
Scott Blood - Vice President of Quality and Regulatory, Access Vascular, Inc.
Scott Blood brings over 30 years of medical device Quality, Regulatory, and Operations experience to this event. Currently, Scott is the Vice President of Quality and Regulatory at Access Vascular, Inc, an early commercial medical device company in Billerica focused on vascular access. Prior to that role, Scott held a similar title at T2 Biosystems in Lexington. Scott has held leadership positions in Quality, Regulatory, and Operations at several companies such as MEDIcept, Solace Therapeutics, NinePoint Medical, Candela Corporation, InfraReDx, Fossa Medical, and Medtronic/PercuSurge, as well as operating his own independent medical device consulting company. Scott is typically the “first Quality guy” or “first Regulatory guy” hired into entrepreneurial medical device pursuits.
Scott is the Past Chair of the Medical Device Division of the American Society of Quality (ASQ), a former member of the Board of Directors of the Massachusetts Medical Device Industry Council (MassMEDIC), and a member of the Regulatory Affairs Professionals Society (RAPS). Scott is currently the Chair-Elect of the RAPS Boston Chapter as well as a frequent lecturer on quality, clinical and regulatory topics relevant to the medical device industry. Scott holds a BS degree from Wentworth Institute of Technology, as well as CQE and CQA certification through ASQ and RAC through RAPS.
Diane Shay - Vice President of Quality and Operations, AION Biosystems, Inc.
Opportunity for Attendees:
Please provide your feedback on any Quality System items you request presented or if you wish to present in the multipart program to: Dennis Shay, NEDG Chair, email address dpshay@gmail.com.
Program Log-on/Access Information:
Two -three days prior to the seminar, you will receive the log-on information for this program. PLEASE MAKE SURE THAT THE EMAIL ADDRESS YOU USE FOR REGISTRATION IS THE CONTACT EMAIL ADDRESS DESIRED for YOUR WEBINAR ACCESS. This email address will be used to provide your log in details to access this seminar. Should you NOT receive these details, please check your SPAM. If you do not receive this link and it is not in your SPAM, please contact us using the links below for Pam Goldtein or Beth Kelly.
We unfortunately cannot offer refunds for cancellations made within 1 week of this event. Refunds requested prior to one week, will be honored, however, the sign-on fees from Member Planet, will be charged. Substitute or replacement persons are always permitted. Please contact the program chair listed if a change is to be made to ensure we have the most up-to-date information on the event’s attendee.
Attendance Certificate Credit:
This will be supplied via email after the webinar with attendance confirmed for the event and released slides.
Registration Information: Note: Registration closes midnight Friday December 5,2025 and seats are limited.
Program Cochair, Pam Goldstein- pgoldstein.qa@gmail.com
Program Cochair, Beth Kelly- bethkellyconsult@aol.com