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


Instructor: Mark Powell
Product ID: 706478
Training Level: Intermediate

  • Duration: 60 Min
This webinar pulls together current US FDA and UK MHRA guidance covering medical devices and diagnostic tests during the current COVID-19 emergency. Particular emphasis will be given to ventilators and other respiratory aids within the medical device topic.
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Why Should You Attend:

Companies making medical devices or diagnostic tests for COVID-19 need to be familiar with these guidances in order to develop and manufacture a marketable product.

The current COVID-19 pandemic has encouraged medical regulators to consider the balance between ensuring the safety and effectiveness of medical devices and their availability to treat the disease. Similarly, the regulators wish to encourage the rapid availability of test kits whilst ensuring that these tests are fit for purpose. This webinar consolidates US and UK guidances in these important areas.

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • Personnel developing diagnostic tests or medical devices
  • Regulatory affairs professionals
  • Medical device manufacturers
  • Diagnostic test manufacturers

Free Materials:

  • Reference documents
  • Rule documents or guidance
  • Checklist
  • SOP template
  • Easy fill in forms
  • Articles
Instructor Profile:
Mark Powell

Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for method development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programs as well as establishing collaborations with academia and instrument manufacturers. His work resulted in a number of published papers and presentations at international scientific conferences. In 2013, he set up his own company to provide training and consultancy services to pharmaceutical professionals. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programs and conducting data integrity audits. He is in demand as a trainer in topics such as chromatography, spectroscopy, pharmaceutical dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies and sample preparation.

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