The Gushu facility in Shenzhen, China, achieved the accreditation after meeting the rigorous audit requirements set by MedAccred subscribing members, including Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics and Stryker.
The FDA is seeking input from organizations interested in collaborating with the agency on the development and execution of the medical device active surveillance system, which is focused around achieving better data capture and detection of potential safety signals in a timely manner. Response required by March 10.
Data integrity issues have plagued the pharma industry since its inception. Blockchain, with its potential to assist in processes from product serialization to data flow tracking, could be the best solution yet.
The acquisition brings MAXIS’ expertise in pre-clinical engineering, design validation and verification, regulatory affairs, field clinical services, and trial management to Avania’s contract research and MedTech development capabilities.
The purpose of the Best Practices in Supply Chain Resiliency and Quality Working Group is to improve medical device quality and supply chain resiliency by expanding MedAccred adoption through the tiers in the supply chain, identifying best practices to supplement efforts in quality assurance and procurement strategies, and to help mitigate supply chain risks.
The guidance defines SLA and non-SLA laser products and provides information on how to request a variance or exemption from SLA class limits.
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.
By deploying connected intelligence systems at a global scale, teams can navigate go-to-market challenges by increasing the transparency and predictability of the complex and divergent global product registration processes.
The FDA is asking stakeholders to submit public comments on how it should use any portion of the user fee funding that may be distributed to external organizations—other than NEST—to support premarket RWE in medical device evaluation and development.
The FDA is hosting a webinar on February 2 for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices.
