FDA Recognizes Computer Simulated Performance Data in Device Evaluation
FDA seeks to draft verification and validation guidelines in response to more medical device manufacturers using computer modeling and simulation....
Apr 17 2013,
Competitive Landscape
What if Your ISO Auditor is Wrong?
Auditors are human. The question is: What should you do when they're wrong?...
Apr 17 2013,
Just Because You’re Trained, Doesn’t Mean You’re Competent
Orthopaedic device manufacturers must define the requirements for each job, evaluate the people in those jobs, develop a gap examination...
Apr 17 2013,
Industry Outlook Remains Positive Despite Excise Tax
Survey finds medical device professionals are more positive about the business environment, excise tax, regulatory environment and emerging markets major...
Apr 17 2013,
Strategic Orthopaedic 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alphatec Spine, Biomecanica Industria e Comerico, Dallen...
Apr 17 2013,
Get Ready for UDI: It’s All About the Data
Orthopaedic OEMs will be among the first to comply with FDA's unique device identification requirements once finalized. However, the complex...
Mar 05 2013,
Lessons Learned From Metal-on-Metal Implants
The FDA is only the latest regulatory body to take investigative action on metal-on-metal implants. What follows is a two-part...
Mar 05 2013,
FDA Releases New Requirements for Combination Products
FDA's final rule on cGMP for combination products provides a definition of these products and the new requirements....
Mar 05 2013,
ASTM Names New Standard for Raw Materials
ASTM added a PEKK raw material standard for medical device implants that if met, will reduce the testing needed to...
Mar 05 2013,
Spotlight on Argentina
Argentina’s orthopaedic device market faces the same challenges as those experienced around the world: pricing pressure and increasing productivity while...
Feb 14 2013,
Entering the Market in Argentina
Argentina’s medical device industry has strengthened along with the country’s economy over the last decade, making it an attractive emerging...
Feb 14 2013,
Develop Orthopaedic Implants Faster Through Auditing
Do your auditing techniques actually improve product development? These three techniques—one simple, one advanced and one new—will shorten the cycle....
Feb 13 2013,
Trademarks vs. Domain Names, Part II: There is a BIG Difference
What happens if your trademark or company brand becomes a victim of cybersquatting? Part II on trademarks vs. domain names...
Feb 13 2013,
Rethinking the Role of Clinical Affairs
“Clinical” has become virtually synonymous with Investigational Device Exemption and Premarket Approval. Really, clinical affairs should be viewed as a...
Feb 13 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Camber Spine, Eleven Blade Solutions, K7, LSK...
Feb 13 2013,