AI was a key theme at OCT Medical Devices 2025, yet human sensibility appears to be the true differentiator in clinical trial ...
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OCT Medical Devices 2025: biggest regulatory requirement issues ‘start at the site level’When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...
Quality Management Systems (QMS) are integral for medical device manufacturers as they ensure adherence to regulations and help in producing top-quality products. Utilizing the right QMS software ...
MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Sep. 2023)), FDA has been focused on cybersecurity in evaluating marketing submissions for ...
Other health systems are discovering that reprocessing single-use medical devices can be a win-win for finances and the environment. Offering reprocessed devices doesn't necessarily translate to ...
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