Learning from Hospital Acquired Infections (HAIs): Understanding Current Reprocessing Regulations, Product Validation and Clinical Human Factors
Watch this exclusive on demand webinar where it will provide an overview of Hospital Acquired Infections, human factors issues encountered in device design and in the healthcare facility, and how to perform a validation for a reusable medical device for use in the healthcare facility. Information on test procedures as well as US and EU regulatory requirements, including new guidance from FDA, will be provided.
Tue, May 19, 2015 - 08:00 am
This webinar will highlight the purpose of having a documented validation plan in place prior to performing any package testing. We will also look at regulatory requirements, examine key considerations when designing, manufacturing, packaging, and testing your medical device, and review what needs to be incorporated into each section of the protocol.
Tue, Mar 24, 2015 - 08:00 am
This webinar provides a basic overview of considerations for establishing a test strategy and test plans for biocompatibility, sterilization and packaging of healthcare products. We will provide examples of some of the common mistakes which we have experienced regarding test strategies and plans. Lastly we present a practical example of developing a biocompatibility testing strategy. The information is intended to help make the regulatory submission and testing processes as smooth as possible.
Tue, Feb 10, 2015 - 08:00 am
This webinar will examine how the “Big Three” biocompatibility tests (cytotoxicity, sensitization, and irritation) are advancing and what those advancements mean for medical device manufacturers. In addition to the Big Three, course registrants will learn about the in vitro sensitization/irritation testing model, and what is being done to ensure regulators accept in vitro alternatives. Additionally, registrants will receive insight into the value of in vitro testing as a means of reducing testing costs, and accelerating time to market.
Thu, Nov 20, 2014 - 02:00 pm
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