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Transitioning from QSR to ISO 13485 Management Report

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

FDA’s New Quality System Regulation:

Transitioning from QSR to ISO 13485

FDAnews Management Report

https://www.fdanews.com/products/62056

Preparing now for the FDA’s new Quality System Regulation (QSR)? Don’t be left behind. Fortunately, FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485 provides everything one needs.

This report answers the key questions that will enable one to prepare for harmonization: Where does ISO 13485 differ from the QSR and how does the FDA intend to close those gaps? When will this happen? How can one get involved in this effort and make sure interests are represented?

Take advantage of upcoming opportunities with FDA’s New Quality System Regulation. Readers will know when and how to take strategic steps to assess current quality systems, apply for ISO 13485 certification and submit comments on/contribute to the proposed rule.

Management report takeaways:

  • FDA’s harmonization efforts — understanding the past to prepare for the future

  • The agency’s next steps, including issuing a proposed rule, preparing a new compliance program and updating inspection procedures

  • Existing tools devicemakers can use to prepare, including becoming familiar with the Medical Device Single-Audit Program (MDSAP) and the international risk management standard, ISO 14971

  • The procedures for release of a proposed rule and how to submit comments on it

  • Comparison of the key provisions of the QSR with those of ISO 13485

Don’t get caught off guard by QSR harmonization. Prepare now with FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485.

Management Report Details:

FDA’s New Quality System Regulation:

Transitioning from QSR to ISO 13485

FDAnews Management Report

https://www.fdanews.com/products/62056

Price:

$197

Easy Ways to Order:

Online: https://www.fdanews.com/products/62056

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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