Hope for New and Improved EU MDR Regulations
The European Parliament recognizes the urgent need to reform device certification and is taking steps to streamline the process....
Feb 24 2025,
Regulations
RAQA Pros Should Focus on Being Celebrated, Not Tolerated
Shouldering the regulatory and quality requirements for their colleagues eases the daily burdens and expedites the work. ...
Jan 14 2025,
3 Regulatory Considerations for Orthopedic Startups
Start up success requires determining the best regulatory path for your device, choosing markets for launch and understanding pertinent guidance...
Jan 13 2025,
Take Some of the Pain Out of FDA Premarket Submissions
Capitalizing on the agency’s ASCA program expedites medical device reviews and adds consistency to the process....
Nov 25 2024,
Ways to Manage the Inherent Challenges of Biocompatibility Assessments
Industry experts share their best advice for meeting FDA's expected endpoints and preparing for scrutiny from the agency’s reviewers....
Sep 24 2024,
FDA Issues Guidance for Predetermined Change Control Plans
Proposed FDA guidance will help orthopedic manufacturers in specifying and seeking premarket authorization for product modifications....
Sep 10 2024,
What You Need to Know to Secure FDA Clearance of 3D-printed Devices
Jeff Brittan, Vice President of Product Realization at SpiTrex Orthopedics, clears up much of the confusion about the process....
Jul 30 2024,
You Need to Prioritize Orthopedic Packaging Solutions
Focus on how devices will be protected, delivered and stored during the initial phases of product development efforts. ...
Jul 24 2024,
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,
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,