RQM+ Weekly Watch #3
RQM+ is a global MedTech service provider focused on accelerating compliance and market success.

RQM+ Weekly Watch #3

This newsletter contains information published through the previous Friday.


RQM+ Recap

RQM+ content published last week and upcoming events.

Technical Briefs

Video/Audio

Upcoming


Europe

  • Further to last week's news post…the presentation of the most recent Notified Body survey on applications and certifications was revised on 11 March 2024, with minor adjustments in some of the charts. Figure 1 below summarizes the survey data in the context of the conformity assessment process.

Figure 1

  • — Another Device-Specific Vigilance Guidance
  • — Three more Common Specifications for IVDs
  • — Updates to all things PMS (guidance and form templates)
  • — More IVDR related guidance


United States and Canada

Rest of World

  • ISO 17665:2024 Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices has just been published. The EN and national versions should be along shortly. This new version replaces ISO 17665-1:2006, ISO/TS 17665-2:2009 and ISO/TS 17665-3:2013 which have all been withdrawn at ISO level and the associated national versions will all be in the process of being withdrawn.


Recalls, FSCAs & Alerts

Class I recall (US)

FDA Safety Communications

European FSCAs / Safety notices:


Warning Letters (United States)


Approvals and Clearances


Articles We Read?

Europe Related

  • All articles we read in this category this week were behind a paywall (we exclude these).

United States Related

General Industry News


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