FDA Issues Draft Guidance for Premarket Submissions of Bone Fixation Solutions
In March, FDA released draft guidance on the information that must be included in premarket submissions for non-resorbable, non-spinal bone...
In March, FDA released draft guidance on the information that must be included in premarket submissions for non-resorbable, non-spinal bone...
The European Commission is providing more time to certify devices, but orthopedic companies should proceed with their transition efforts....
Vast amounts of data are available to accelerate the innovation of new products, but tapping into that information is no...
Orthopedic companies can use the information to incorporate the tools into their research, development and regulatory efforts....
FDA is recommending comprehensive cybersecurity risk management programs and documentation consistent with device quality systems....
The agency said that its new analysis findings would inform a long-awaited air pollution rule that could have consequences for...
ASTM international is seeking participating manufacturers and test labs to support reproducibility requirements of the new standard....
MedTech Europe concluded there's an urgent need for immediate action to help keep needed medical devices available in Europe....
Got a potentially noteworthy or novel device? Here are some tips to help determine the best regulatory submission pathway....
Advice on how to Make Sense of the IQ/OQ/PQ alphabet soup....
Medtech say they’ll begin to prioritize the U.S. market first....
Notified Bodies have recommended companies submit their applications 18 months in advance. That means manufacturers need to submit their MDR...
FDA's guidance focuses on the credibility of CM&S in medical device submissions....
FDA's discussion paper outlines scenarios in which hospitals might 3D-print devices and asks industry for comments. ...
Orthopedic companies that manufacture medical software products are required to manage the life cycle of their medical device software....
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