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.
The European Commission developed the new proposal following a December 9, 2022, meeting of the EPSCO Council, where EU Ministers of Health called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Device Regulation. The proposal will now be negotiated by the European Parliament and the Council.
Mitigating risk of failure is one of the most important disciplines to perform for medical device manufacturers, and for the last couple of years, it has become an increasingly difficult discipline to master.
