Practical Ways to Comply with FDA’s QMSR Final Rule
You have two years to make the necessary adjustments and the required changes shouldn't involve a heavy lift. ...
You have two years to make the necessary adjustments and the required changes shouldn't involve a heavy lift. ...
A final rule released by the agency intends to reduce overall EtO emissions from sterilization facilities by 90% and 21...
Submit your feedback on proposed premarket submissions for orthopedic devices that contain metallic or calcium phosphate coatings....
The organization is planning education sessions about the standards and regulatory guidelines that impact the OEM and supplier relationship....
Answers to commonly asked questions that provide clarity on ways to ensure medical devices are protected against data breach threats....
Updated guidance has created confusion about test protocols, led to regulatory deficiencies and postponed product launches. ...
Explore the feasibility of using real-world evidence to enhance product development and what it will take to overcome its limitations....
The European Commission is concerned with the lack of applications that have been received by notified bodies....
Submitting your thoughts and suggestions about the planned recommendations helps to clarify the intent of final guidance documents....
The year ahead presents exciting opportunities to increase collaboration within the orthopedic industry and advance patient care. ...
Learn about the information that needs to be documented during the development, verification and validation of software-enabled devices....
The recommendations detail how to support premarket submissions for devices designed to implement preoperative plans created by surgeons....
OSMA's spring meeting focused on the areas in which industry is running into the most trouble during regulatory submissions....
Companies must assess the Unitary Patent (UP) System to determine the best fit for the technology they want to protect....
In March, FDA released draft guidance on the information that must be included in premarket submissions for non-resorbable, non-spinal bone...
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