Compliance Isn’t Accidental: A Case for Management’s Commitment to Quality
Leadership must foster a culture of business and quality equilibrium to drive long-term product and company success. That commitment involves...
Jan 13 2015,
Regulations
ISO 55000 Released to Assist Operations Leaders with Financial Management
As the orthopaedic industry adapts to the rapidly changing worldwide healthcare market, it can learn from the failures of other...
Jan 13 2015,
Conflict Minerals Due Diligence: Strategies for a Successful Second Filing
May 31, 2015 is the second filing deadline for the conflict minerals due diligence disclosure rules. Here are some key...
Jan 13 2015,
FDA Publishes Priorities for 2015
FDA’s Center for Device and Radiological Health issued its list of priorities for 2015, including guidance documents it intends to...
Jan 13 2015,
EU Proposes Significant Changes for Importers and Distributors
The EU’s proposed Medical Device Regulation will subject companies within the supply chain to the same rules, which differs from...
Dec 10 2014,
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,
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,
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,