Practical Application of Risk Management for EU MDR
2:00 PM - 2:45 PMTue
Speakers
Vinny Sastri, Ph.D.
President
Winovia, LLC
* Implementation of Risk Management that complies with both the EU MDR and ISO 14971 Requirements * Requirements for Technical Documentation * Strategy for remediation of existing product on the market * Addressing General Safety and Performance Requirements with respect to Design Controls and Risk Management * Identifying and addressing gaps * Establishing a risk review process that takes into account post-market data and trending