Sponsored Webcast: QMSR Final Rule: Navigating Implementation and Demonstrating Compliance

The Medical Devices Quality System Regulation Amendments final rule was published on 2 February 2024 with an effective date of 2 February 2026. Medical device manufacturers have been preparing for implementation through gap assessments, updates to procedures and processes, and training personnel. Implementation focus for the medical device industry have been in the areas of risk management, terminology updates, and content of inspections.

Key changes for inspections are:

1. The QMSR does not include the exceptions that existed in §820.180(c) of the QS regulation
2. The Quality System Inspection Technique (QSIT) will be withdrawn. In its place will be the Compliance Program, where inspection of medical device manufacturers will be updated to document the inspection process for the QMSR.

At this free webcast, industry representatives along with FDA’s Karen Masely-Joseph will cover implementation expectations in key areas including an overview of the Compliance Program that will be released on 2 February 2026. Participants will be able to submit questions in advance of the event.

Registration Fees & Deadlines

Learning Objectives

• Expectations for implementation of the QMSR Final Rule
• Understand the updates to the compliance program for inspections of medical device manufacturers
• Key resources where manufacturers can look for guidance

Who Should Attend?

Quality, Regulatory and Operations supervisors, managers, directors, VPs, Stake holders and personnel interested in understanding expectations for implementation and compliance to the QMSR final rule and changes to the associated FDA inspection process.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Speakers

FDA Speaker

Karen Masely-Joseph
Office of Medical Device and Radiological Health Inspectorate, Senior Advisor, FDA

Julie Larsen is a managing principal at BioTeknica, an IQVIA business what provides regulatory compliance, quality, technical and engineering services to the medical device, biotechnology and pharmaceutical industries. Julie is a medical technologist (MTASCP), Certified Quality Manager (CQM), and has more than 35 years’ experience in quality assurance and compliance in the medical device, pharmaceutical, and biologics industries. Julie has extensive experience with strategy, coordination, and management of FDA inspections, quality systems remediation for compliance improvement and constructing responses and corrective action plans for Consent Decree, Warning Letter and Form 483 responses as well as development of quality systems. As a consultant Julie has spoken at multiple conferences and held webinars on the topics of internal audit programs, compliance, quality system, and FDA inspections. Julie earned her bachelor’s degree in medical technology from Rush University and a bachelor’s degree in science and liberal arts from Monmouth College.

Julie Larson
Managing Principal, BioTeknica

Jodi Scott
Partner, Hogan Lovells

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions