On May 16-17, the MedTech Regulatory Intelligence Summit will bring regulatory affairs professionals and members of the FDA together for two days of education, discussion and networking as we look at challenges and best practices in navigating current and on the horizon regulatory requirements.
Share your research, experience and expertise with your peers at the upcoming Medtech Advanced Manufacturing Conference and Medtech Supply Chain Intelligence Summit. Call for abstracts is now open.
IVDR has significant implications for the manufacturing of IVD devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Wiktoria Banczyk, Product Manager Lab Filtration Medical Devices at Sartorius Lab Instruments, discusses the challenges posed by the implementation of EU IVDR 2017/746 and key considerations for manufacturers as they navigate today’s regulatory landscape.
Selecting a strong medical device contract manufacturer is critical to ensure supply chain resiliency, regulatory compliance, and long-term success for a medical device OEM. This article is a guide to the most important questions to ask yourself and your contract manufacturer to help ensure a successful partnership.
If finalized, EPA’s proposals are estimated to cut EtO emissions to the air from commercial sterilization facilities by 80% per year and apply more protective standards to control those emissions under the law. But MedTech advocates are concerned that the EPA is overlooking the controls already in place and a lack of alternatives that could lead to patient risks.
The nonclinical assessment model (NAM) can predict the rise and distribution of temperature in bone around metallic femoral nails when exposed to radio frequencies during an MRI scan.
The CDRH notes that the goal of the guidance is to put safe and effective advancements in the hands of healthcare providers and users more quickly to help increase the pace of medical device innovation in the U.S. and enable more personalized medicine.
New data presented at the Technology and Heart Failure Therapeutics (THT) Conference showed that hemodynamic monitoring can slow the progression of heart failure in patients with reduced ejection fraction.
The final guidance includes recommendations for various elements of animal studies, including the credentials for personnel conducting an animal study, and the study planning and conduct process, including selecting an appropriate animal model, study monitoring, and study evaluation.
Only one third of “The State of ESG in Manufacturing” survey respondents have high confidence in the quality and accuracy of their supply chain data. This article summarizes the risks of poor data, the seven elements that contribute to siloed data, and the associated regulatory risks.
