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. ...
Mar 26 2024,
Regulations
EPA Strengthens its Stance on Reducing Toxic EtO Emissions
A final rule released by the agency intends to reduce overall EtO emissions from sterilization facilities by 90% and 21...
Mar 19 2024,
Comment on FDA’s Draft Guidance for Orthopedic Implant Coatings
Submit your feedback on proposed premarket submissions for orthopedic devices that contain metallic or calcium phosphate coatings....
Mar 05 2024,
OSMA Sets its Sights on OMTEC
The organization is planning education sessions about the standards and regulatory guidelines that impact the OEM and supplier relationship....
Feb 22 2024,
What You Need to Know About FDA’s Final Quality-Based Cybersecurity Guidance
Answers to commonly asked questions that provide clarity on ways to ensure medical devices are protected against data breach threats....
Feb 13 2024,
New Biocompatibility Regulations Frustrate Orthopedic Companies
Updated guidance has created confusion about test protocols, led to regulatory deficiencies and postponed product launches. ...
Jan 31 2024,
Building the Pathway to Successful Use of RWE
Explore the feasibility of using real-world evidence to enhance product development and what it will take to overcome its limitations....
Jan 15 2024,
Act Now to Meet the EU MDR Deadline
The European Commission is concerned with the lack of applications that have been received by notified bodies....
Jan 08 2024,
Act Now to Comment on FDA Proposed Guidance for 2024
Submitting your thoughts and suggestions about the planned recommendations helps to clarify the intent of final guidance documents....
Nov 21 2023,
Looking Forward to Evolving and Meeting New Needs
The year ahead presents exciting opportunities to increase collaboration within the orthopedic industry and advance patient care. ...
Nov 20 2023,
FDA Provides Clarity on Premarket Submissions for Medical Device Software
Learn about the information that needs to be documented during the development, verification and validation of software-enabled devices....
Sep 11 2023,
FDA Guidance Improves Review of Patient-matched Guides
The recommendations detail how to support premarket submissions for devices designed to implement preoperative plans created by surgeons....
Aug 07 2023,
OSMA Highlights Industry Troubles with FDA Guidance on Biocompatibility, MRI Labeling
OSMA's spring meeting focused on the areas in which industry is running into the most trouble during regulatory submissions....
May 22 2023,
Are You Prepared for the EU’s New Patent Protection System?
Companies must assess the Unitary Patent (UP) System to determine the best fit for the technology they want to protect....
May 08 2023,
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...
Apr 26 2023,