Join Lachman Consultants for a webinar that will equip medical device companies with the knowledge to navigate the upcoming FDA QMSR changes set for 2026.
Preparing for the FDA’s Quality Management System Regulation (QMSR) Rollout in 2026 – Understanding the changes and aligning with ISO 13485 Webinar
December 16, 2024
12:00 PM – 1:00 PM
Preparing for the FDA’s Quality Management System Regulation (QMSR) Rollout in 2026 – Understanding the changes and aligning with ISO 13485 Webinar
December 16, 2024
12:00 PM – 1:00 PM
Join Lachman Consultants for a webinar that will equip medical device companies with the knowledge to navigate the upcoming FDA QMSR changes set for 2026. Key topics include a thorough understanding of the new regulations, how they integrate with ISO 13485, and what companies need to do to maintain compliance. Attendees will gain insights into the practical steps required to update quality systems, prepare for FDA inspections, and avoid compliance pitfalls during the transition. This is a must-attend for quality and regulatory professionals in the medical device industry.
Meet The Speakers
David Day, Director of Compliance, Lachman Consultants
David Day, M.Sc. is a Director at Lachman Consultants with 20+ years of experience in the medical device industry. Career highlights include attainment of MDR 2017/745 certification for Class III medical device, multiple successful FDA inspections, Notified Body and ANVISA audits. He has worked on a wide variety of products from conventional vascular devices to combination products.
He is a quality and regulatory professional who brings strong technical skills across a range of areas – Quality Systems, Operations, Change Management and Design Assurance. He is experienced in Quality Management Systems compliant to 21 CFR 820, 21 CFR Part 4 and ISO 13485. He is proficient in EU MDR 2017/745, MDD 93/42 and UK MDR 2002. He has been responsible for technical file development, Post Market Surveillance programs, Internal Audit programs and continuous improvement projects. He has extensive Project Management experience in complex regulatory and product changes. David is also proficient in external audit preparation and management with Notified Bodies (BSI, TUV, Dekra), FDA and ANVISA.
Deanna Anderson, Sr. Director of Medical Compliance, Lachman Consultants
Deanna Anderson is a Senior Director at Lachman Consultants who has more than 25 years of pharmaceutical, medical device and combination products experience in Quality Assurance, Compliance, Manufacturing and Laboratories. A practiced audit and compliance management professional with experience working collaboratively with top leaders and staff to optimize adherence to policies, procedures, standards, and regulations. Career highlights include experienced in comprehensive analysis of operations, recommending process improvements, introducing best practices, and supporting development of talented teams. Experienced leader of site remediations to address regulatory agency enforcement actions.
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