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.
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