QMSR ISO 13485 Integration – 2024 Changes to FDA 21 CFR 820

Course Summary

This training provides an overview of recent FDA 21 CFR 820 changes to Quality Management System Regulations (QMSR), especially related to the integration of ISO 13485:2016.

Event Details

4 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually

Description

In February 2024, the FDA published the final rule for the Quality Management System Regulation (QMSR), integrating ISO 13485:2016 standards. This article details the QMSR’s implications, emphasizing the strategic adjustments medical device companies must make for compliance.

The QMSR applies to manufacturers, contract sterilizers, installers, relabelers, remanufacturers, repackers, specification developers, and initial distributors of foreign manufacturers. Additionally, component manufacturers are encouraged to voluntarily comply with the QMSR.

The harmonization between QSR and ISO 13485 addresses several challenges medical device manufacturers face. Historically, navigating the differences between regulatory regimes has been complex and resource-intensive. Misalignment between QSR and international standards often led to duplicative efforts, increased compliance costs, and delayed market entry. Manufacturers looking to enter the U.S. have been unable to fully leverage their ISO 13485 compliance, while U.S. manufacturers looking to enter the E.U. have needed double compliance to align their QSR-compliant quality systems to ISO 13485.

Harmonization offers a strategic solution to mitigate these challenges while fostering several key benefits:

  • Global Market Access: By aligning regulatory requirements, harmonization promotes mutual recognition of standards, facilitating market access across diverse regions.
  • Enhanced Consistency: Harmonization fosters consistency and clarity in regulatory expectations, reducing ambiguity and interpretation discrepancies.
  • Operational Efficiency: Harmonization streamlines processes, eliminates redundancies, and optimizes resource allocation, enabling manufacturers to focus on innovation and product development.

Risk management is a requirement throughout ISO 13485:2016 and this course covers a summary for risk management in each of the elements.

This half (1/2) day training will inform you on recent FDA 21 CFR 820 changes to Quality Management System Regulations (QMSR), especially related to the integration of ISO 13485:2016.

Who Should Attend

  • ALL companies who make a medical device regulated by the FDA
  • Senior Management
  • Regulatory Management
  • Marketing Management – Strategic Planners and Post-Market Surveillance
  • Quality Managers and Associates
  • Auditors: Internal & 3rd Party external auditors
  • Consultants advising clients on making the upgrades to the new QMSR
  • Design and Development Engineers and Management

Learning Objectives

  • Understand the primary changes from QSR to the QMSR
  • Understand the importance of creating a Quality Plan to effectively plan for the changes
  • Understand the Technical Documentation requirements compared to the obsolete Technical File requirements
  • Re-emphasize the risk management requirements of ISO 14971:2019 and ISO/TR 24971:2020
  • Identify the necessary steps as to prepare an organization to transition to the QMSR requirement

Course Outline

  1. High-level overview of the planned QMSR changes
  2. In-depth review of the planned QMSR changes
  3. Implementation timeline
  4. Strategy for deployment so the company’s QMS complies to the new QMSR regulation
  5. Connecting with the appropriate Notified Body or Certification Body

Prerequisites

Working knowledge of FDA QSR and/or ISO 13485 requirements

Instructors

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