EU MDR: How to Respond to Today’s Knowns and Unknowns
Orthopedic device companies implementing EU MDR should consider these eight actions, while thinking strategically about the unknowns of the regulation. ...
Orthopedic device companies implementing EU MDR should consider these eight actions, while thinking strategically about the unknowns of the regulation. ...
Artificial intelligence technology is evolving quickly, and the potential benefits of adaptive AI systems in relation to modern medicine are...
Orthopedic and coating manufacturers are leading the discussions with ASTM, ISO and FDA to set standards and guidance for current...
When it comes to solving complex problems, such as the orthopedic device design control process, the incompetency and laziness from...
The National Evaluation System for health Technology Coordinating Center launched its first round of Real-World Evidence Test-Cases, which include...
This more modern 510(k) pathway is to be used for clearance of low- to moderate-risk devices. It has a focus...
By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that...
Martin Browning from EduQuest provides insight into the validity of e-signatures from vendors: "Validation must include documentation, or it is...
In order to stay current with the evolving technological landscape and increased insight into cyber threats, FDA recently addressed cybersecurity,...
Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of...
Recent updates to standards and regulatory guidance have made sterilization processes more complex....
Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are...
OEMs must be aware of and comply with design control requirements included in 21 CFR, Part 820. Unsafe, ineffective devices...
OEMs must engage partners in conversations about the information needed from each party for Medical Device Regulation in order to...
An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the...
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