The Impacts of the QMSR Changes to Combination Products

Event Time

Wednesday, October 16 9:30 AM - 10:00 AM Central Time (US & Canada)

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Event Location

Location: Room 103 A


Event Information

Title: The Impacts of the QMSR Changes to Combination Products

Description:

The FDA recently announced the changes of the QSR, 21 Part 820, to the newly introduced QMSR that harmonizes with ISO 13485 for medical devices. But did you know, these changes have an impact in Part 4 and the requirements around Combination Products as well? Join in this session where we will highlight the regulatory changes, the impacts to combination products, and steps companies can take now to stay ahead of the curve.

Type: Theater Session


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Categories

Education Level

  • All

Pass Type

  • 1 Day MD&M Conference Pass (Wednesday)
  • 2 Day MD&M Conference Pass
  • Media
  • Speaker

Session Theme

  • Quality & Regulatory

Sessions

  • MD&M: Medical Device R&D & Implementation
  • MD&M: Medical Regulatory & Quality Requirements

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