It’s best to be sure you understand the defensible, fact-based market need for your great idea before investing significantly in an intuitive belief of its potential.
The new European MDR and IVDR regulations feature several significant changes and, while many medical device manufacturers already have started implementation efforts, this article aims to provide a quick summary of the key changes, aiding organizations in their transition plans.
This article explains the basics of project risk management and how to execute it, and the vital role clinical data play in product risk management, so the clinical trial manager can be better prepared to both manage risks in their trial projects and participate more fully in the device's product risk management effort.
A survey of about 200 medical device professionals examined how challenging it can be to balance innovative product design with compliance and risk management; the survey also looked at time-hungry tasks, technological advancement, and design methodologies.
As more stakeholders become involved with automation, AI, and general data management in healthcare applications, the move toward a combination of all three aspects will create healthcare solutions equivalent to sci-fi aspirations.
Thanks to the huge culture surrounding comic books and Japanese manga, a rich body of work has emerged investigating the comprehension of visual narratives. Here, we explain how some of the cognitive principles and theories resulting from this research can be straightforwardly applied to QRGs.
Transcatheter mitral valve devices will continue to expand into clinical practice as people age out of open-heart surgical operations, and technology and innovation for mitral valve diseases will continue to improve.
Can we optimize clinical trial design by considering patients’ urgency for new therapeutic options, as well as their willingness to accept uncertainty? A nearly two-year collaboration — between the FDA Center for Devices and Radiological Health (CDRH), Parkinson’s patients (via The Michael J. Fox Foundation Patient Council), MIT, RTI Health Solutions, and the Medical Device Innovation Consortium (MDIC) — aimed to find out.
How will changes to the ISO 14971, the medical device risk management standard, and its accompanying guidance document, ISO TR 24971, an ISO Technical Report, affect your company?
A medtech seeking payer coverage can only really control its own ability to articulate and prove its technology’s market value, while anticipating the myriad variations in coverage requirements. Virtually everything — from stakeholders to priorities to standards for evidence — is subject to change.
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