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
- Artificial Intelligence for literature and
- The impact of social media on post market
- Ways to save time and resources while
achieving and maintaining compliance
- Methods of searching and identifying post market
data in timely manner
- 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.
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.