Elos Medtech’s Advantage Lies in Nimble Approach to Serve Orthopaedic Customers
As part of its strategy to become a global solutions provider to the medical device industry, Elos Medtech acquired U.S....
May 10 2017,
Competitive Landscape
Orthopaedic Industry Revenue Reaches $48.1 Billion
Orthopaedic industry revenue reached $48.1 billion worldwide in 2016 and grew at 3.2%, ~$1.5 billion over 2015, according to our...
May 09 2017,
When Do I See a CAPA Specialist?
If your company struggles with deciding when to elevate a complaint to the level of a CAPA, how do we...
May 08 2017,
FDA 510(k) Insights: March Clearance Highlights
Strategic FDA 510(k)s released in March 2017 include a cannula from AJU Pharm, Bodycad's uni knee, a new company from...
Apr 12 2017,
Value Analysis Committees, EU’s MDR Highlighted in OMTEC Surgeon Keynote
Increased regulatory scrutiny and payor power continue to affect healthcare globally, leading companies to create cross-department teams and seek collaboration...
Apr 11 2017,
How to Reduce Cost and Lead Times While Maintaining Margins
OEMs and suppliers can reduce cost and lead times while preserving or improving margins with numerous initiatives that don't require...
Apr 11 2017,
Design Intent: Do I Need to Perform Verification and Validation?
If you’ve characterized a material change to your medical device and confirmed no impact to any of your design inputs...
Apr 11 2017,
Clinical Data and CE Mark: What are We Doing Wrong?
A reader informed us that companies are failing the clinical evaluation portion of the initial CE Mark or audit process,...
Mar 27 2017,
Reducing the 1% Failure Rate through Testing & Analysis
John McCloy offers solutions to reducing the 1% failure rate of medical implants through testing & analysis...
Mar 07 2017,
Once an Easy Path, Europe’s Regulatory Approval Toughens
Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval....
Mar 07 2017,
NuVasive Ahead on In-House Manufacturing Hires
The company machined 40,000 pieces in its Ohio manufacturing facility in 2016....
Mar 07 2017,
Exactech Divests Spine Assets
ChoiceSpine expands breadth of product and global distribution with acquisition....
Mar 07 2017,
Suppliers Prioritize Additive Manufacturing Initiatives to Start 2017
Carpenter, GE, Materialise and Siemens announce collaborations, acquisitions to address additive technology....
Mar 07 2017,
China’s Medtech Policy Sets Path for Orthopaedic Manufacturers
The Chinese government has prioritized medical device development, as well as local and international investments by domestic device companies. These...
Feb 08 2017,
FDA Update: Final Guidance on Medical Device Reporting
FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is...
Jan 11 2017,