4 Human Factors Practices that Lead to Successful FDA Submission
Nearly 90% of FDA 510(k) submissions receive reviewer comments related to human factors engineering. While these four practices are likely not...
Nearly 90% of FDA 510(k) submissions receive reviewer comments related to human factors engineering. While these four practices are likely not...
FDA has made multiple announcements in recent weeks, including the return of domestic inspections as well as decisions on De...
FDA's CDRH Director Dr. Jeffrey E. Shuren emphasized the need for a greater focus on Advanced Manufacturing during the MDIC...
In our latest Ask the Expert article, we answer how software validation fits with your SOPs for design validation and...
The goal of the CDRH reorganization was to drive operational efficiencies. Some organizations will feel the impacts of changes more...
The European Parliament voted to postpone MDR until 2021. The regulation's postponement now moves to its final steps. ...
FDA’s Center for Devices and Radiological Health issued a letter to industry regarding what to expect as companies and the...
The European Commission will propose delaying the MDR deadline by one year. The announcement came after MedTech Europe and others...
Question: How do I handle medical device risk management and the change from ALARP to AFAP? Virginia Anastassova of StarFish...
FDA released draft guidance for 510(k) submissions of arthroscopy pump tubing sets intended for multiple use after receiving reports of...
The medical device risk management standard was updated to better align with changes in medical device regulations around the world....
Removal of these procedures from the inpatient-only list makes them eligible to be paid by Medicare in hospital outpatient and...
FDA has prioritized the reduction of ethylene oxide to sterilize medical devices. Recent announcements from the agency provide orthopedic manufacturers insight...
The United States Patent and Trademark Office has enacted policy changes to post-use audits and foreign applications. The new laws...
Companies affected by this change include RTI Surgical, marketer of the SImmetry® system, and SI-BONE, manufacturer of the iFuse Implant...
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