MedTech organizations need to focus on the human factor of change and achieve top-down alignment, buy-in, accountability, and clear communication along the way.
Recently, biocompatibility consultant, MedTech enthusiast and chemist, Marina Daineko, shared a series of LinkedIn posts defining, medical device biocompatibility and the need for a Medical Device biological risk assessment “framework.” Following is a reposting of Marina’s original LinkedIn series.
Fraudulent data is becoming more common by the submission. So much so that the FDA recently published a press release reminding medical device manufacturers to scrutinize Third-Party Generated Data.” Regulatory consultant, Michelle Lott, discusses the agency’s use of artificial intelligence to find unusual patterns in submitted data and how you might guard against using fraudulent 3rd-party data.
To streamline processes, enhance transparency, and improve the overall efficiency of conducting clinical trials in the EU/EEA, the 3-year transition period from the CTD to the CTR requirements was established. With the end of the transition period approaching, all ongoing clinical trials that were approved under the CTD will have to be fully be transitioned to comply with the CTR. Failure to comply by 2025 will bring serious consequences.
How does smart packaging improve medical device logistics operations? Learn about examples and explore how you might apply them.
nsuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key frameworks play a crucial role: ISO 14971:2019 and the FDA Quality Management System Regulation (QMSR). This essay explores their individual contributions and how they work synergistically to enhance medical device safety.
Navigating the conformity assessment process – examination of a manufacturer’s technical documentation and quality management system – requires a thorough understanding of the different routes and options available for various risk classifications of medical devices and IVDs, while knowledge of the conformity assessment process helps manufacturers prepare effectively and manage expectations. This blog offers guidance for creating successful conformity assessments.
Light field technology is illuminating a path to a deeper understanding of patient anatomy, surgeon methodology, and surgical environments. Traditionally, spine surgery navigation has depended on surgeons combining pre-operative imaging with intra-operative anatomy to execute their treatment plans. However, with light field technology and depth sensors, these technologies digitize the entire operative field, merging it seamlessly with preoperative imaging, effectively bridging the gap between unseen and visible physical anatomy of the spine. This provides surgeons with a three-dimensional anatomical view that exceeds what the naked eye can discern.
This blog explores the transformative potential of AI assistants in healthcare management and delves into the benefits for providers, medical assistants, and obviously, patients.
As medical technology products and services move through the development pipeline, they face the challenge of both showing safety and efficacy for regulatory approval and articulating the value of the diagnostic, treatment or monitoring technology to obtain reimbursement from payers. A 2024 MedExec Women Conference panel highlighted strategies to bridge the evidence needs for regulatory approval and reimbursement to more efficiently bring products to market.
