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International Consensus Standard for Medical Device Manufacturers

After years of waiting, the FDA has finally sent its QMSR final rule to the White House for review and clearance. The industry should expect the QMSR final rule to be released either in late December or early Q1 2024.

As stated in the final rule's abstract, the revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485 : 2016.

Part of the FDA’s reasoning for harmonizing its regulations with ISO 13485 is reducing the regulatory burden for device makers by eliminating redundancies involved in complying with both the ISO and QSR standards.

Below some of the changes the regulation would bring:

  • An emphasis on risk management activities and risk base ddecision making
  • Clarification on the application of certain rules to certain device types
  • Extension of traceability requirements
  • A focus for top management on establishing a culture of quality
  • A formal introduction and definition of the word customer
  • An updated concept of a QMS
  • QSIT replacement
  • Conforming amendments to the cGMP rules that apply to combination products

Here are some suggested strategic steps for readiness:

  • Adopt ISO 13485:2016 standards. Companies unfamiliar with ISO 13485 should consider updating their quality systems to comply directly with these standards. This move is beneficial for those primarily operating within the U.S. or in non-ISO 13485 countries.
  • Consider MDSAP certification. Engaging in the Medical Device Single Audit Program (MDSAP) is a wise strategy. MDSAP allows firms to undergo a single audit that satisfies quality regulations for multiple countries, including the U.S., Canada, Brazil, Japan, and Australia. Pursuing MDSAP certification can replace routine FDA inspections with notified body audits, providing efficiency and aligning with international standards. It also ensures compliance with ISO 13485 criteria, putting companies ahead in meeting the upcoming QMSR requirements. 
  • Guard against complacency. Continuous evaluation and updating of compliance strategies are crucial.
  • Develop a cross-reference/matrix document. Both ISO 13485 compliant companies and those new to the standard should create a cross reference or matrix document.  This tool is invaluable for educating employees about the quality system and its compliance targets. It serves as a foundational guide for aligning current practices with the anticipated QMSR requirements.

The QMSR, in its currently proposed form, introduces a new framework for the medical device QSR, which the industry has been waiting for. Certain suggested modifications are likely to have a substantial impact on many firms. Impacted companies may also want to consider strategizing harmonization efforts now.

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