FDA Posts 510(k) Communication Timeline
FDA has developed a timeline that provides 510(k) applicants with an understanding of communication during the review process....
Jan 15 2014,
Knee Innovation Focused on Materials, Design and Computer-Assisted Improvements
FDA Promotes Voluntarily Correcting Violations with New Program
FDA recently announced details of a new pilot program that will allow medical device companies to voluntarily identify and correct...
Jan 15 2014,
Tegra Medical Appoints J. Mark King as CEO
Mr. King joined Tegra Medical in 2012 with 20+ years of broad-based operations, sales, engineering and manufacturing experience in medical...
Jan 15 2014,
Auditing Process Validation & Developing Protocols
Have you ever had to perform a process validation protocol for a new piece of equipment or acquired a process...
Jan 15 2014,
Baum Precision Machining Earns ISO 13485 Certification
SRI Quality System Registrar is pleased to announce that it has awarded an ISO 13485:2003 Management System certificate to Baum...
Jan 09 2014,
Ceram Changing Name to Lucideon
On February 1, Ceram materials technology group will change its name to Lucideon to reflect its expanding portfolio....
Jan 07 2014,
Emuge Appoints President of U.S., Canada Operations
Emuge Corp., a leading manufacturer of taps, thread mills, toolholders, clamping devices and other rotary cutting tools, has announced the...
Jan 02 2014,
RAM Healthcare to Launch Incubator Facility in Indiana
RAM Healthcare Group will launch its incubator facility in Fort Wayne, Indiana. The group has developed a distribution and inventory...
Dec 20 2013,
Medical Tracking Solutions Announces New Client, Custom Spine
Medical Tracking Solutions, developers of iTraycer, has added to its client roster Custom Spine, developer of spinal implants and instruments for...
Dec 16 2013,
Precision Micro Machining Capabilities Expand with Makino’s UPN-01 Wire EDM
Makino announces the release of the UPN-01 ultra-precision horizontal wire EDM for micro-tolerance and fine surface finish applications. Designed with...
Dec 13 2013,
Defining Innovation
What is innovation? It’s not just one thing. Read what orthopaedic professionals had to say on its definition and development....
Dec 12 2013,
The Hague Agreement: It May Save You Money
The Hague Agreement more closely aligns U.S. design patent laws with the international community. It also provides flexibility when filing...
Dec 11 2013,
U.S. OIG Issues POD Report; Reliance Medical Files a Suit
The U.S. Office of Inspector General of the Dept. of Health and Human Services' overview of prevalence and use of...
Dec 11 2013,
Rising Obesity Rates Driving Surge in U.S. TKR
The rise in obesity rates in people under age 65 appears to be having a dramatic influence on the number...
Dec 11 2013,
National Joint Registry for England, Wales and Northern Ireland: Findings from 10th Annual Report
The NJR Steering Committee launched its tenth report in late September. Data from more than 1.4 million procedures are now...
Dec 11 2013,