Trending Technology: Metal Injection Molding
Metal injection molding has garnered attention in the orthopaedic industry, due to the technology’s ability to produce complex shapes at...
Dec 10 2014,
Competitive Landscape
Why Won’t My CAPA Process Work?
Having a viable CAPA process in place is critical, in a time of frequent recalls, increased warning letters for repeat...
Dec 10 2014,
Unique Device Identification (UDI): Many Questions Remain
FDA issued its final rule requiring medical device manufacturers to assign and label products with UDIs more than a year...
Dec 10 2014,
How to Get the Most Out of Your IP Firm
Device companies often mistakenly focus solely on patents to protect their ideas. Taking this narrow approach could hurt the long-term...
Dec 10 2014,
21 Notable Products from 2014
What new products made your list of most innovative in 2014? Here is a list of some of the more...
Dec 09 2014,
Strategic Orthopaedic-related 510(k) Update
Discover which orthopaedic companies recently received strategic FDA 510(k) clearances to market their products....
Dec 09 2014,
FDA Extends UDI Compliance Date for Certain Orthopaedic Implants
A variety of fixation screws, plates and spinal devices will not need to meet UDI labeling requirements until 2016....
Dec 09 2014,
Preparation for Spinal Reclassification Under Way, Despite Pending EU Regulations
While the EU has yet to set a completion or implementation date for spine implant reclassification, manufacturers shouldn’t wait to...
Nov 07 2014,
Uncover Opportunities in Your Supply Chain Challenges
Overcome challenges in the orthopaedic device supply chain with these tips on how to leverage new technologies, enter new markets,...
Nov 07 2014,
FDA Focuses on Properties and Biocompatibility of AM Medical Devices
Understand FDA’s current thinking on the regulatory process for additive manufactured devices....
Nov 07 2014,
FDA Surveillance Inspections and Warning Letters Decrease
A CDRH quality system data report offers insight into common observations from 2013. Familiarize yourself with these trends and action...
Nov 07 2014,
FDA Addresses Custom Device Exemptions
FDA clarified changes to the Custom Device Exemption provision through a final guidance document....
Nov 07 2014,
FDA Seeks 21st Century Agility with 510(k)s
FDA introduced several changes, including new initiatives to clarify the 510(k) submission process. How will these changes affect your device’s...
Oct 02 2014,
Can I Make, Use and Sell My Patented Invention? The Answer May Surprise You
Obtaining a patent does not always guarantee the ability to build and commercialize your invention. Follow these tips to avoid...
Oct 02 2014,
Strategic Orthopaedic-related 510(k) Update
See which orthopaedic companies recently received 510(k) clearances to market their products....
Oct 02 2014,