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1/2-Day 2024 Changes to FDA 21 CFR 820: QMSR ISO 13485 Integration

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

Days: .5

Time: 7:30 AM- 11:30 AM MST

Audience: Beginner to Advanced

Overview

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.

You’ll receive an understanding of the following:

  • The FDA’s announcement on January 31, 2024, to integrate ISO 13485:2016 into the new 21 CFR 820 QMSR
  • New implementation timeline
  • Real examples of what’s new, and what is being removed or becoming obsolete
  • Examples of what is still required by FDA regulations until February 2026
  • The integration of ISO 14971 – Risk Management Files in the QMS
  • The importance of getting started RIGHT NOW to create the Quality Manual, etc.
  • Medical Device Single Audit Model (MDSAP) and how impactful it can be to the QMS and audit program

Who Should Attend

  • ALL companies who make a medical device regulated by the FDA (Class I, II and III)
  • Top/Senior Management – Strategic Planners
  • Regulatory Management – Strategic AND Tactical Planners
  • Regulatory Associates – Tactical – “Doers” of the work
  • 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
  • Product Risk Managers

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
  • The importance of MDSAP

Agenda

  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. The importance of MDSAP
  6. Connecting with the appropriate Notified Body or Certification Body

Course Certificate

Participants will receive a 21 CFR 820 & ISO 13485:2016 QMSR Training Certificate.

Date/Registration