Regulatory Open Forum

My upcoming RAPS European Workshop, Rollout IVDR 2022: How to prepare for the IVDR by May 2022. Date of Application or Dead on Arrival? will cover these big themes of the IVDR with hands-on information on how to tackle the most important requirements. Elements that are going to be covered are:<o:p></o:p>

-Most important elements of the IVDR and focus areas when implementing<o:p></o:p>

-Developing a strategy for regulatory compliance in accordance with the IVDR<o:p></o:p>

-Performance Evaluation process and documentation requirements<o:p></o:p>

-Reviewing and effectively implementing IVDR requirements into Technical dossiers and QMS<o:p></o:p>

-Integrating Risk Management and Post Market Surveillance into the QMS<o:p></o:p>

-Management of the implementation of the IVDR project<o:p></o:p>

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This is a multi-day virtual workshop that will be divided into four separate live sessions. <o:p></o:p>

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Part I –  23 March, 2022 – 13:00 CET – 17:30 CET (8:00 AM ET - 12:30 PM ET)<o:p></o:p>

Part II - 24 March, 2022 – 13:00 CET – 17:30 CET (8:00 AM ET - 12:30 PM ET)<o:p></o:p>

Part III - 30 March, 2022 – 13:00 CET – 17:30 CET (7:00 AM ET - 11:30 AM ET)<o:p></o:p>

Part IV - 31 March, 2022 – 13:00 CET – 17:30 CET (7:00 AM ET - 11:30 AM ET)<o:p></o:p>

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You can learn more here. I hope to see you there! Feel free to ask any questions below in the replies.<o:p></o:p>