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2020 - FDA and MHRA Guidance during the COVID-19 Emergency: Medical Devices and Diagnostic Tests

Date2020-05-25

Deadline2020-05-15

VenueOnline Event, USA - United States USA - United States

KeywordsDiagnostic tests; Fda guidance for covid-19; Mhra medical device guidance

Websitehttps://www.complianceonline.com/fda-and...

Topics/Call fo Papers

Exceptional use applications for non-CE marked devices
Requirements for continuous positive airway pressure (CPAP) devices
Requirements for ventilators
Expedited advice service
Validation of changes to medical devices
Clinical investigations (including protocol deviations)
Diagnostic tests – regulatory pathway
Diagnostic tests – validation requirements

Other CFPs

  1. Medical Device Industry Trends for Computer Systems Regulated by FDA
  2. Understanding Key Quality System Requirements for Combination Product (Medical device and Pharmaceuticals) Manufacturers
  3. FDA Inspection Readiness
  4. Risk Management - A Process Flow Approach to Converting a Guidance into an SOP

Last modified: 2020-05-07 00:31:38