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,
Regulations
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,
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,
Passing Brazil’s Inspections to Take Product to Market
Over the past few years, I have had the opportunity to help orthopaedic medical device companies prepare for and logistically...
Jan 16 2013,
Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations
FDA’s multi-layered rules for product recalls can resemble a double-edged sword. Have you under-reported your recall? Over-reported? How can you...
Dec 17 2012,
The Quality Review Board: A Conduit for Success
Your Quality Review Board exists to ensure continual improvement to your Quality Management System. How do they stack up as...
Dec 17 2012,
Trademarks vs. Domain Names, Part I: There is a BIG Difference
What happens if there is a dispute over the use of your domain name, or if someone is using your...
Dec 14 2012,
Strategic Planning for Regulatory Compliance
Will you wait until your company has an unannounced audit by a Notified Body? Or will you develop a Quality...
Dec 13 2012,
FDA Draft Guidance: Refuse to Accept 510(k) Policy
On August 13, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This guidance explains procedures and...
Oct 04 2012,
The IPXI® – An Alternative to the License Agreement? Maybe!
Monetizing intellectual property is the process of deriving tangible value from the IP or the technology that is protected by...
Oct 04 2012,
Unique Device Identification: From Compliance to Value
FDA issued a proposed Unique Device Identification rule requiring manufacturers of medical devices to uniquely identify their products....
Oct 04 2012,
Medical Device Excise Tax: Achieving Compliance with Confidence
Complying with indirect taxes is a legal mandate that is not core to a business, yet the operational outlay is...
Oct 04 2012,
Complaints: A Second Chance to “Make it Right”
Customer complaints can give medical device companies a wake-up call when they're not achieving their fundamental purpose: that is, meeting...
Oct 04 2012,