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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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FREE ON-DEMAND WEBINAR

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

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.

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Kapstone webinar - PMS
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
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Hosted by

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Presenter: Carolyn Guthrie

Director of QA/RA, Kapstone Medical
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Moderator: Jesseca Lyons

Senior Medical Device Guru, Greenlight Guru
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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About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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