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FREE ON-DEMAND WEBINAR

Post-Market Surveillance for Medical Devices and Combination Products: If a device is FDA cleared or approved, can we assume it’s safe and effective?

When a medical device or combination product is cleared or approved by FDA, can we assume it’s safe and effective?

In a word… NO!

Only 3-5% of adverse events are reported to manufactures or FDA.  Spun in reverse… 95-97% of adverse events are never reported!  If problems are not reported, can we conclude our devices are working perfectly?  Is the absence of evidence, evidence of absence?

Post-market surveillance (PMS) is the process of watching our devices perform while on the market.  PMS is a vital component of the medical device and combination product lifecycle.  Yet historically, the med-tech industry has had a poor record when it comes to PMS.  As a result, PMS requirements have been increasing in the US, the EU and around the globe.  But having an effective PMS system means more than simply meeting the regulatory and quality requirements. 

A strong PMS system cannot simply find problems that may have been missed as part of the pre-market development or quality assurance process.  A strong PMS system can be used to add additional indications, a.k.a. label expansions, which translates to greater revenues for the manufacturer!

Having an effective PMS system is important from both a regulatory and quality perspective.  But can you assume if your PMS system meets the regulatory and quality requirements, that its effective? that its working? Absolutely not!  And when companies make such assumptions, they often find themselves in trouble… not just with the FDA but with product liability attorneys as well! 

In this presentation, participants will learn best practices to avoid timely and costly mistakes as well as creative ways to use post-market surveillance to their advantage! 

Watch the webinar

MDrues webinar - PMS Device-Combo
This presentation will use the case study approach to take a broad look at medical device and combination product post-market surveillance in an interactive fashion including:
  • What are the key elements of an effective PMS system?
  • With increasing pre-market regulatory requirements, do we still need PMS? 
  • Is passive PMS enough? What about active PMS?
  • What is the role of risk management in PMS?
  • How do we integrate usability into PMS?
  • What about PMS for combination products?  How does device PMS compare to drugs?
  • How can PMS be used for label expansions? Either via RCT and/or real-world evidence?
  • How do we meet PMS regulatory requirements without increasing product liability risk?
  • How is PMS similar and different in the US vs. EU?
  • What are the PMS challenges for the future, i.e., PMS for personalized devices including 3D printing?
  • Q&A Session
Who Should Attend?
  • Medical Device Industry Executives
  • Quality Professionals and Management
  • Regulatory Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management
Additional columns, articles, podcasts and webinars can be found: Global Medical Device Podcast, Mike on MedTech (Medical Product Outsourcing) here, Medical Design and Outsourcing here, Guerilla Regulatory Strategy (MED Device Online) here and Healthcare Packaging here or LinkedIn here.
Register Now

Hosted by

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Presenter: Mike Drues

President, Vascular Sciences

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Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About Vascular Sciences
Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website tolearn 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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