Finite element analysis (FEA) is an important tool in assessing the mechanical integrity of load-bearing medical implants. The development of standards for FEA and model credibility requirements are enabling the credible use of modeling in the regulatory setting. It is important to establish trust that the model outputs are sufficiently accurate and reliable for a […]
Summer 2019 Event Recap
August 23, 2019 by
The MDRG summer event took place last week on August 15th 2019 at the Sheraton Minneapolis West. Guests arrived over the lunch hour to listen to two different panelists give their perspectives on the topic for the day, “Current Cyber Security Considerations for Medical Devices”. The panel was moderated by Charles Garcia, Vice President of […]
Are you on track to comply with the EU Regulation for medical devices?
May 15, 2019 by
The EU Medical Devices Regulation (MDR) entered into force on 25th May 2017, signaling the start of the transition period. The transition period for the MDR is three years. This transition period ends on the date of application, that is 25th May 2020. Therefore, we are roughly half way through the transition period. In June 2018, […]
Bacterial Endotoxins Testing: Justifying an Alternative to Batch Testing
April 16, 2019 by
On March 21, 2019, QTS Principal Sterilization Specialist Sopheak Srun gave a presentation at the AAMI Sterilization Standards Committee Microbiological Methods Working Group (WG08) meeting in Arlington, VA, on a risk-based approach for justifying an alternative to batch release bacterial endotoxins testing. QTS sterilization specialists Sopheak Srun and Molly Swanson have been active members of […]