Navigate the Increasingly Complex Audit Landscape with Ease
Industry experts shared invaluable insights and perspectives during an informative panel discussion at OMTEC 2024. ...
Jul 24 2024,
Regulations
Leveraging Real-world Evidence for Equitable Device Evaluation
Orthopedic companies seek clarity from FDA on leveraging clinical data to achieve regulatory approval during the product development process. ...
May 29 2024,
New Guidance Highlights FDA’s Evolving Thoughts on AI and ML
The Orthopaedic Surgical Manufacturers Association dedicated its recent Spring Meeting to addressing the digital health regulatory landscape....
May 16 2024,
Excel in Getting Digital Health Technology to Market
OSMA's Spring Meeting focused on the the regulatory landscape for surgical robots, navigation and surgical planning software....
May 01 2024,
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,
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Comment on FDA’s Draft Guidance for Orthopedic Implant Coatings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,