Packaging Design Validation Testing
Manufacturers of medical devices must ensure that their terminally sterilized products are contained within validated packaging to...
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An Introduction to Radiation Dosimetry and the Mathmatical Model
This webinar offers an in-depth overview of radiation dosimetry, focusing on essential principles and calibration methods required...
How to Address Regulatory Change in Your Current Biocompatibility Program
This course is designed to help you stay abreast of the latest changes in regulatory standards, including...
Regulatory Landscape for EO Residue Levels in Medical Devices
The global regulatory landscape around Ethylene Oxide (EO) residues is a topic of increasing interest. This webinar...
Ethylene Oxide Sterilization, Revision of Annex E, Single Batch Release
ANSI/AAMI/ISO 11135:2014 Annex E has recently undergone significant revisions, expanding the requirements for the release of products...
New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016
Product family grouping, as discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013, titled ‘Sterilization of Health Care Products...
Performance Qualification for Gamma Irradiators
Sterilization validation is a critical phase in the lifecycle of sterile products. This webinar will focus on...
Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Health Care Application
In March 2017, the new ISO 18562 standard series was released, comprising four parts that address the...
Packaging Design for Sterilization
Bringing a medical device from conception to market involves numerous critical steps, one of which is often...
Clinical Evaluation Requirements for Medical Device – Meeting Medical Device Clinical Evidence Requirements – CE Marking
Clinical Evaluations are mandated by the Medical Device Directive (MDD) to ensure the safety and efficacy of...