Evaluating the Need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

FREE ON-DEMAND WEBINAR

Evaluating the Need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

The medical device industry is no stranger to change.

In fact, a medical device and its support system may undergo hundreds of changes throughout the duration of the product life cycle.

From improved design, new suppliers, better processes, or supplier change notification, we are constantly dealing with the impact of change.

Knowing how to properly evaluate and manage all areas that are impacted by a change is a critically important process for manufacturers to master.

In this free webinar, biocompatibility and risk subject matter expert Thor Rollins from Nelson Laboratories will present proven ways in which manufacturers can evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical device.

Learn how to evaluate possible safety impacts following any change that is made and how to effectively mitigate biocompatibility risks.

Watch the webinar

Specifically, this webinar will cover:

Guidance on which changes would be considered impactful and which ones are low risk
What procedures can be put into place to evaluate and deal with changes
What information is needed before a change can be evaluated
Planning the cheapest and easiest test system to accept the change
Implications for your risk management processes
Q&A session

Who Should Attend?

Medical Device Executives
Human Factors and UX Professionals
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management

Hosted by

Presenter: Thor Rollins

Director, Toxicology and E&L Consulting, Nelson Labs

Moderator: Taylor Brown

Senior Medical Device Guru, Greenlight Guru

NelsonLabs600

About Nelson Labs

Nelson Labs®, a Sotera Health company, is an industry-leading, global provider of laboratory testing and expert advisory services. We perform over 800 rigorous microbiological and analytical laboratory tests across the medical device, pharmaceutical, protective barriers, and tissue industries. We know that every test matters and requires solutions to complex problems to improve patient outcomes and minimize client risk. Visit their website to learn 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.

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