Optimizing CER and PMS Document Writing with Technology and AI 2023 | MedTech Intelligence | 25 September 2023 | Webinar

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This session will delve into common non-conformities encountered during clinical evaluations and explore how technology can play a pivotal role in resolving these challenges. We will also discuss practical process adjustments made to prevent the recurrence of these non-conformities in subsequent reviews. Gain insights into the practical application of technology to address regulatory hurdles and improve submission outcomes.

You'll Learn :

To develop a clear understanding of the specific criteria and key aspects that notified bodies prioritize during their review of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Clinical Development Plans (CDPs)

Practical strategies and tips to enhance efficiency when managing regulatory documentation.

Gain insights into viewing technology as a powerful tool for long-lasting compliance and ease of maintenance. As well as learn to see technology adoption not just as a short-term solution, but as a strategic investment that pays off in sustainable regulatory compliance and streamlined maintenance processes.

Who Should Attend:

• Medical Device Manufacturers
• Top management / VPs
• R&D managers
• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Medical Device Executives
• Technical Writers and Managers
• Medical Writers / Reviewers
• Medical Device Executives
• Clinical Managers

2023 Speakers

Pratibha Mishra
Manager, Medical Device Services Celegence

Shruti Sharma
Product Specialist, Regulatory Services
Celegence

2023 Sponsor

• Celegence