Free On-demand webinar

Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive

Watch the free Webinar

 

This webinar will focus on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) set to go into enforcement in May 2020. 

These new PMS requirements push the manufacturer to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current.

Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered.

Analysis of data to ensure appropriate actions are taken, such as updating technical documentation or device improvements, is performed according to predefined criteria.

During this free 60 minute webinar hosted by Carolyn Guthrie, Director of QA/RA at Kapstone Medical, you will learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.

Specifically this webinar will cover: 

  • Understanding the new requirements of PMS under MDR
  • What is the impact to the business?
  • How do the requirements affect your current product lifecycle approach/QMS?
  • Relationship between PMCF and PMS
  • What to include in your plans and reports?
  • Q&A Session

Who should attend?

  • Medical Device Executives
  • Product Development Engineers
  • Product Managers
  • Regulatory Affairs Professionals
  • UX Designers

 

 

 

Presenter

 Carolyn Guthrie

Carolyn Guthrie
Director of QA/RA
Kapstone Medical

Moderator

 Jesseca round

Jesseca Lyons
Senior Customer Success Expert
Greenlight Guru

 

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About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.

Kapstone Medical   

 
 
ABOUT Kapstone

Kapstone Medical, founded in 2007, is a single-source service provider to medical device companies lacking the appropriate human capital to commercialize new and safe products. We offer customized solutions that are flexible and cost effective in an ever changing regulatory environment. Our services span five main areas:  product development, quality assurance, regulatory affairs, intellectual property strategy, and manufacturing solutions. Visit our homepage to learn more. 

 

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