Understanding The Many Connotations Of Risk In Medical Device Development And The Consequences Of Getting Them Wrong

Risk mitigation in the medical device industry typically starts with a brainstorming session: the product development team randomly rattles off risks and writes them down.

This “cherry-picking” approach is a haphazard process because whether you spend an hour or a year, you can never be certain you have captured all the important risks.

Suffice it to say, this webinar is not the typical ISO 14971, QMS or Design Control approach which although commonly followed, all take a very limited view of risk and are simply not adequate for regulatory submissions.

During this free 90 minute interactive webinar, a more systematic, engineering-minded approach to risk is presented.

Watch the webinar

Multiple examples of actual medical devices are used to demonstrate specifically
      • What are the three buckets of risk and how to apply them?
      • What’s the difference between a risk mitigation strategy and a risk management plan?
      • How to deemphasize or not draw attention to certain risks?
      • What’s the relationship between risk mitigation and product liability?
      • How to handle risks in off-label uses without creating product liability nightmares?
      • How to factor regulatory risk into the equation

Ultimately risk is not a simple matter. There are many different connotations of risk.

Medical device manufacturers need to understand the impact of risk mitigation strategy on a regulatory submission as it can make or break a submission, especially if it’s a 510(k) or de novo.

Your risk management plan is also very important, not just to meet the design control requirements, but in terms of product liability, as well.

A successful medical device manufacturer must carefully consider not only what you say regarding risk and how you say it, but also what you don’t say and how you don’t say it!

Hosted by

M.Drues Headshot circle (3)
Presenter: Mike Drues

President, Vascular Sciences

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


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.


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.

Featured In