FDAnews Announces CDRH’s Proposed Rule Harmonizing QSR and ISO 13485: Everything Devicemakers Must Know and Do to Prepare Webinar November 30, 2021

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What does one do when CDRH harmonizes QSR with ISO 13485? Prepare now to ensure device quality system compliance. Register today.

WCG FDAnews

WCG FDAnews

CDRH’s Proposed Rule Harmonizing QSR and ISO 13485:
Everything Devicemakers Must Know and Do to Prepare
An FDAnews Webinar
Tuesday, Nov. 30, 2021, 1:30 p.m.-3:00 p.m. EST
https://wcg.swoogo.com/cdrhs-proposed-rule-harmonizing-qsr-and-iso-13485

Quality systems must change. What does one do when CDRH issues its quality system regulation (QSR) draft proposed rule due before the end of 2021?

Devicemakers will need to use more modern risk management principles and align quality systems more closely with ISO 13485. While the specific timing of the draft and final rule are unknowns, there are key changes one must understand now and strategic steps one can take to get ready.

Julie Larsen, a principal consultant and director of inspection readiness services at BioTeknica, Inc., will share these changes and steps so you can stay compliant:

  • What the anticipated significant changes are, in the proposed rule will be, including the ways in which quality and ISO 13485 will be more harmonized
  • The anticipated timing for the final rule and expectations for compliance, including more advanced risk management techniques
  • Key changes devicemakers must make to their quality systems, including those that will be necessary to harmonize with ISO 13485
  • What the implications will be to risk management processes in general, including how to devise systems to ferret out errors in quality control management

Wait for the draft proposed rule and one is already behind. Prepare now and stay compliant.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
CDRH’s Proposed Rule Harmonizing QSR and ISO 13485:
Everything Devicemakers Must Know and Do to Prepare
An FDAnews Webinar
Tuesday, Nov. 30, 2021, 1:30 p.m.-3:00 p.m. EST
https://wcg.swoogo.com/cdrhs-proposed-rule-harmonizing-qsr-and-iso-13485

Tuition:
$297 per site

Easy Ways to Register:
Online: https://wcg.swoogo.com/cdrhs-proposed-rule-harmonizing-qsr-and-iso-13485
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
FDAnews
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