2025 SECTION MEETINGS
March 12, 2026
Membership meeting in Maine
Complaints and Adverse Event Reporting for Medical Devices by Dan O'Leary CMDA, CQA, CQE, CRE, SSBB
Thursday March 12, 2026 from 5:30 pm to 8:00 pm
Venue: Hilton Garden Inn Portland Airport in Portland, ME
Registration: https://mp.gg/3a2xtc8bni
Medical devices are an important sector in the US economy. When they provide benefit to patients they fulfil their purpose. Unfortunately, this is not always the case; patients or user may be harmed by a medical device. Harms result in complaints to the manufacturer which may require adverse event reports to regulators.
The presentation explores the complaint process, particularly the changes resulting from FDA’s Quality Management System Regulation, QMSR, which went into effect in February 2026. While each regulatory region has its own adverse event reporting system, the presentation looks at the US and the EU systems, comparing and contrasting the methods.
March 17, 2026
Membership meeting in New Hampshire
Complaints and Adverse Event Reporting for Medical Devices by Dan O'Leary CMDA, CQA, CQE, CRE, SSBB
Tuesday March 17, 2026 from 5:30 pm to 8:00 pm
Venue: Puritan In manchester, NH
Registration: TBD
Medical devices are an important sector in the US economy. When they provide benefit to patients they fulfil their purpose. Unfortunately, this is not always the case; patients or user may be harmed by a medical device. Harms result in complaints to the manufacturer which may require adverse event reports to regulators.
The presentation explores the complaint process, particularly the changes resulting from FDA’s Quality Management System Regulation, QMSR, which went into effect in February 2026. While each regulatory region has its own adverse event reporting system, the presentation looks at the US and the EU systems, comparing and contrasting the methods.
Wednesday March 25, 2026
Granite State Webinar
Acceptance Sampling by Dan O'Leary CMDA, CQA, CQE, CRE, SSBB
Cost; $30.00
Venue; On-line
Registration: TBD
Acceptance sampling is one of useful tools in quality control, often applied at incoming inspection. The webinar follows the ASQ Certified Quality Engineer Body of Knowledge section IV.C.
Topics include risk, operating characteristic curves, AQL, attribute sampling, and variables sampling. The webinar explains using the Z1.4, c=0, and Z1.9 sampling plans.
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