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AI for Post Market Surveillance Compliance and Regulatory Work According to MDR (On-Demand)

1.5 RAC Credits Member: $0.00 Nonmember: $25.00
AI for Post Market Surveillance Compliance and Regulatory Work According to MDR (On-Demand)

This is an On-demand recording from February 2020.


With the imminent approach of EU MDR's 26 May implementation deadline, companies that sell Medtech products within the EU need to prepare for drastic change. Meeting the demands of the new regulations, especially for post market surveillance, will consume more time and resources than ever before. In preparation, companies should investigate the available tools and technologies for achieving post market surveillance compliance effectively and efficiently. By attending this webcast, you'll learn actionable tips and strategies for saving time and money while achieving post market surveillance compliance under the new EU MDR.

This webcast will cover:

  • How to reach compliance with post market surveillance under MDR
  • Best practices for achieving post market surveillance compliance
  • Artificial Intelligence for literature and content search
  • The impact of social media on post market surveillance
  • Ways to save time and resources while achieving and maintaining compliance
  • Methods of searching and identifying post market data in timely manner

 

Learning Objectives

  • Identify what needs to be done in order to comply with new post market surveillance requirements
  • Perform a GAP Fit analysis in order to accelerate the internal work required to reach compliance
  • Evaluate technologies designed to make performing post market surveillance more effective and efficient

 

Who Should Attend?

  • Anyone utilizing literature and vigilance database review for regulatory submissions or data identification, regardless of experience or seniority.

 

Speakers


Helene Quie, CEO, Qmed Consulting

Helene Quie has over 20 years of experience in the pharmaceutical and medical device industries, specializing in device development, quality management, project management, clinical trial execution and market access. In 2006, she founded Qmed Consulting, a private consultancy specializing in medical device development and clinical trials. Helene has a degree in cellbiology from the University of Odense and has worked for Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S.

 

Marcus Emne, founder & CEO, Hoodin

Marcus Emne has over 20 years of experience in data science and advanced analytics. In 2014, he founded Hoodin, a software-as-a-service (SaaS) company that specializes in content monitoring for the life science industry, leveraging insights and data analytics. Marcus presently serves as the CEO of Hoodin, a public company listed on the Swedish stock exchange.

 

Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.


Questions

For account support, contact the RAPS Support Center: Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

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