WEBINAR 11 | How successful medical device companies de-risk post-market surveillance
Learn how integrating eQMS and cloud connectivity facilitates effective compliance, reducing cost and risk.
✔️ Presented by:
Chris DuPont, Co-Founder, and CEO - Galen Data
Jon Speer, Founder - Greenlight Guru
Post-market surveillance monitors and reports the safety and effectiveness of medical devices available for use by the general public.
It is often a required activity and always a wise business objective. Post-market surveillance recognizes that despite well-planned and executed clinical trials, commercial medical device deployment may reveal unanticipated characteristics.
Traditional methods of monitoring product performance and adverse events, collecting relevant information, and reporting to regulatory bodies are time-consuming and prone to human error. Many aspects of performing post-market surveillance can be automated and streamlined using an electronic quality management system such as Greenlight Guru’s eQMS.
Cloud connectivity platforms, such as the Galen Cloud, facilitates real-time collection and analysis of surveillance data.
Moreover, an integrated eQMS and cloud strategy is highly effective and provides significant efficiencies, and creates business opportunities.
Key webinar takeaways:
• What is post-market surveillance and why is it important?
• For what types of medical devices is post-market surveillance required?
• What are the important global issues?
• How do post-market surveillance requirements differ between 21 CFR part 822 and ISO 13485:2016?
• What are the limitations of a traditional manual process?
• How do eQMS and cloud connectivity result in more effective and efficient post-market surveillance?
• What business opportunities result from integrating eQMS and cloud connectivity?
Contact Galen Data for your healthcare connectivity needs:
👉 www.galendata.com/contact/
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Timestamps:
00:00 Webinar Introduction and Speakers.
00:52 Jon Speer and Greenlight Guru Introduction.
03:14 Chris DuPont and Galen Data Introduction.
05:57 Webinar Topics for post-market surveillance.
07:52 What is post-market surveillance?
13:50 Current "status quo" process.
20:08 Enhancements gained using eQMS.
23:50 Enhancements gained using Cloud Connectivity.
29:29 eQMS and Cloud Connectivity.
39:02 Your Next Steps...
42:12 Questions and Answers.
59:00 Outro.
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