Ace Your Next Test
Changes to regulations and standards as well as innovation in materials and design make it a challenge to keep up...
Oct 03 2013,
FDA Clarifies 510(k) Pathway for Bio-Gate’s Silver Antimicrobial Coating
How to Find Savings in the Excise Tax Era
There is much more to the medical device excise tax than reporting and remitting. Some manufacturers might benefit from re-evaluating...
Oct 03 2013,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances: Advanced Interventional Technology, CoreNexus, Crosstrees Medical, Emerge Medical, Ingen Orthopedics, JG...
Oct 03 2013,
Mitigate Patent Infringement Risk with an FTO
Performing an FTO search is a critical tool when developing or getting ready to launch a new product. Here's how...
Oct 03 2013,
Zoning In with Howard Levy
Howard Levy joined Biomet and the orthopaedic device industry in 2007, after serving in global strategic sourcing leadership positions that...
Oct 03 2013,
Risk Management: The Science of Minimizing Uncertainties
The success of a risk management process in medical device manufacture lies in an early start in design and use...
Oct 02 2013,
Millstone Medical Outsourcing Hires New Director of Quality in Olive Branch, MS
Mr. Haire comes to Millstone with 22 years of quality-focused experience at one of the top orthopaedic device manufacturers in...
Oct 02 2013,
Measuring and Assessing the Cost of Manufacturing Cells and Lines
If a company is to understand the benefits that accrue as a result of cellularization, it cannot follow an obsolete,...
Oct 02 2013,
Consumers Union Seeks Warranties to Support Hip, Knee Implants
The Consumers Union is asking U.S. manufacturers to back products with a 20-year warranty. Other suggested requirements include the following....
Oct 02 2013,
The Anatomy of a Successful Design Plan
Did your latest project plan end with another line extension and the cold reality that your team was eight weeks...
Oct 02 2013,
Presenting Data to Show Product Cost Effectiveness
Shifts in the marketplace are driving a need to collect and position clinical data in order to show product effectiveness....
Oct 01 2013,
A Natural Fix: Absorbable Textiles Improve Reconstruction from the Inside Out
Slowly and steadily, biomedical textiles are garnering increasing attention from OEMs across all therapeutic sectors. As the range of biomaterials...
Oct 01 2013,
LayerWise Nominated Finalist in 2013 Flanders’ Most Promising Company Awards
LayerWise is nominated a finalist in the 2013 Award of Flanders’ Most Promising Company. With this award, the Flemish Government...
Sep 24 2013,
FDA Finalizes UDI Requirements
Final rule does not mandate direct part marking for implantable devices, provides manufacturers of Class III implants one year to...
Sep 24 2013,
UFP Technologies Expands Manufacturing Operations in Illinois
UFP Technologies, producer of custom-engineered components, products and specialty packaging, expanded its Glendale Heights, Illinois manufacturing operations to meet the...
Sep 17 2013,