TORONTO, ON--(Marketwired - April 05, 2017) - In a live presentation on April 18, 2017, industry expert Audrey Turley, research scientist at Nelson Laboratories, will outline the steps for developing a Biological Safety Evaluation (BSE). BSEs are useful tools when assessing the biocompatibility of a medical device based on the risk to patient safety as outlined by the ISO 10993-1 standard and the FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.'"
The three main steps in developing a BSE are:
- Biological Evaluation Plan (BEP)
- Testing and Written Risk Assessments
- Biological Evaluation Report (BER)
BEPs are test plans developed to assess the patient safety risk of a medical device based on the materials and manufacturing processes of the device, and the intended direct and indirect patient exposure. A BEP is useful to narrow the scope of tests necessary when evaluating the safety of a medical device, which can save manufacturers time and money.
The BEP is crucial to help manufacturers understand the biological endpoints that are required for testing as the approach for determining device safety has recently moved to scientific justification (from the traditional checkbox-based approach). Scientific justification determines when testing is necessary and when it is not -- which can include chemistry testing.
As biological safety evaluations become more complex, BERs are essential to draw the right conclusions from the data submitted to support the overall safety of a medical device. A written assessment is requested in ISO 10993-1 as well as in the FDA guidance document. The webinar will review the information that should be included in the report.
This webinar will be comprised of a 50-minute presentation followed by a Q&A session.
Join Audrey Turley on Tuesday, April 18, 2017 at 1pm EDT (10am PDT). For more information or to register for this complimentary event, visit: Developing a Biological Safety Evaluation.
Established in 1985, Nelson Laboratories, LLC is a business unit of Sterigenics International LLC and a leading provider of microbiological testing and consulting services for MedTech companies. We know that every test matters and requires solutions that improve patient outcomes and minimize client risk. It means working with customers to solve complex problems, providing precise test results, and delivering value through superior testing solutions and service to ensure the safety and efficacy of every product. Visit www.nelsonlabs.com for more information.
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, to private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
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