Event Date: November 14, 2017 - November 16, 2017
This three-day workshop offers attendees an opportunity to gain a more comprehensive understanding of ethylene oxide and radiation sterilization methods, microbiological basics, biocompatibility, reusable device and cleaning validations, materials characterization, and how to validate your sterilization and manufacturing process. NOTE: Seminar is RAPS and ASQ approved, eligible for 12 RAC and 1.8 ASQ credit hours. Course may also qualify for AAMI credit hours.
Event Date: October 3, 2017 - October 6, 2017
Nelson Labs is exhibiting at the 41st Annual Meeting of the AATB. Our experts will be in Booth #12 for complimentary consultations and to answer your questions.
Event Date: April 19, 2017
The three main steps in developing a Biological Safety Evaluation (BSE) are 1) Biological Evaluation Plan (BEP), 2) Perform Testing and Written Risk Assessments, and 3) Biological Evaluation Report (BER). A BEP is developed based on risk of the device to the patient. With this in mind, several factors need to be considered to ensure that unnecessary testing is avoided. A useful testing plan will address the device as a whole, starting with materials and processes and ending with patient exposure (type and duration).