Medical Devices and IVD manufacturers often face multiple challenges in the process of getting certified from the notified bodies. The challenges include delays in review of application from notified bodies, gaps in the application and dossier, missing information and others. The gaps further delay the go-to-market for manufacturers resulting substantial loss of potential revenue.

 

Artixio presents an insightful webinar to highlight some of these challenges and strategies to mitigate potential risks before applying for certification to notified bodies. The distinguished expert for the webinar is Mr. Shailendra Singh, Senior General Manager Medical and Health Services South Asia and Global Head of Biologics Testing from TUV SUD, who will share insights based on his experience working with manufacturers. The session will address several topics including,

 

• Preparation required before submitting the application to notified bodies

• Strategies for reducing time for review of application

• Minimising gaps in the application

 

The webinar will be of 45 minutes which includes 15 minutes of Q&A session where participants will have the opportunity to ask questions.