Computational modeling is an important supplement to physical testing and clinical trials for design and performance validation of medical devices. The Food and Drug Administration’s (FDA) guidance material, “Reporting of Computational Modeling Studies in Medical Device Submissions”, includes guidelines for providing statistical proof and validation of simulation results such as inclusion of “the sensitivity of the QOI(s) [quantity of interest] on key parameters and provide a systematic analysis of the uncertainty in relation to the key parameters, as appropriate” (FDA Guidance Section 10a, 2016).

The performance of periodic sterilization dose audits is required, where a sterilization dose has been established using Method 1, Method 2, or Method VD_max. This webinar will focus on the purpose and activities associated with such audits in order to demonstrate the continued effectiveness of the established sterilization dose. Participation in this webinar will provide you with the understanding of why the sterilization dose audit is needed and how to complete a dose audit for a wide variety of medical devices that have been validated using the ANSI/AAMI/ISO 11137.

The new Medical Device Regulations (MDRs) become enforceable May 2022. After that, all new devices set for market in the European market will have to demonstrate compliance with ISO 10993, even if the device has been on the market for years.

An overview of radiation dosimetry will be given with emphasis on dosimetry principles and calibration methods in order to maintain measurement traceability. The importance of estimating measurement uncertainty is discussed, including how uncertainty can be applied to the radiation process, and to assess new product process capability for new products. An introduction to the mathematical model is also given with emphasis on how it can be used to complement radiation dosimetry, and assist with the validation of an irradiator change.

This webinar is focused on catheter shaft componentry with a deeper dive into polytetrafluoroethylene (PTFE) liners and fluorinated ethylene propylene (FEP). Information provided will contain a mix of polymer material science, specifications of extruded fluoropolymers, engineering considerations for fluoropolymer use and processing of those. We will also cover new developments for PTFE as well as FEP heat shrink including the ultrathin (less than .001” wall thickness) extruded liners and peelable heat shrink.

Designing and developing surgical tools that heat tissue for necrosis requires understanding the temperature distribution that develops during the use of the device. Multiphysics simulation enables designers to understand and address the interaction of the heat source with the body in order to develop devices that target specific tissue without damaging the surrounding healthy tissue.

Global production of Polylactic Acid (PLA) is increasing dramatically as it becomes the biodegradable plastic of choice for a wide range of medical and industrial applications. PLA requires a specialized recycling plan…is your company ready? Attend this Webinar to learn what you need to know to prepare for the PLA revolution.

Biosensors and point-of-care devices are poised to change the delivery of healthcare. This 60-minute Webinar from the editors of Medical Design Briefs explores cutting-edge developments and their role in the future of medical devices.

A novel method for recycling PLA using low-temperature, low-pressure reactions with alcohol or water has been discovered by Zeus Research. PLA is used today in many applications ranging from food packaging to implantable medical devices. Because of its sensitivity to thermal degradation, PLA is difficult to recycle and actually becomes a contaminant in the plastics stream of municipal solid waste.

This presentation will describe the benefits of parametric release and how best to establish a compliant and capable process design. Topics covered include: