How to Proceed When a Testing Standard Doesn’t Exist
Orthopaedic device innovation is evolving, and there will be gaps in device testing standards and guidance. Here are three proactive...
Jul 01 2015,
Regulations
Purchasing Controls: Draft the Best Supplier Quality Agreement
Quality agreements are an essential management tool to prevent supply chain problems. The best contracts clearly define the extent of...
Jul 01 2015,
Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s
Frustrated with FDA’s 510(k) search function, Eric Eggers created kBLASTER to help companies simplify and speed their 510(k) submissions....
Jul 01 2015,
FDA Outlines Stance on ex-U.S. Clinical Data
In a recent draft guidance, FDA describes what device companies should consider when submitting OUS clinical data for regulatory approval...
Jun 09 2015,
FDA Launches Searchable UDI Database
FDA recently announced the launch of AccessGUDID, a website that allows users to search and download information on devices that...
Jun 09 2015,
Mobile Medical Apps Attract OEM, FDA Attention
Mobile communication devices are radically changing the way we think and make decisions about our healthcare. Manufacturers developing medical mobile...
Jun 09 2015,
Training Your IP Police Force to Catch Infringement
It is critical for all companies to establish and properly train their own IP police force to enforce their own...
May 12 2015,
Big Changes in ISO 13485:2015?
On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. How will new...
May 12 2015,
CDRH Proposes Nationwide Postmarket Surveillance System
The Center for Devices and Radiological Health has proposed a National Medical Device Postmarket Surveillance System expected to serve the...
Apr 08 2015,
How to Avoid Risky CAPA Decisions
When non-conformity is identified, your company must determine the significance, the associated risk and the potential for recurrence. Manufacturers must...
Mar 24 2015,
You Secured a Utility Patent; Now What about Your Design Patent?
Recent high-profile lawsuits have demonstrated the importance of design patents to protect inventions. Understand the difference between a design and...
Mar 04 2015,
The Basics: Understanding the Medical Device Single Audit Program
MDSAP was launched to leverage resources of regulatory bodies in the U.S., Canada, Brazil and Australia to monitor device manufacturers....
Feb 10 2015,
CAPA+2, UDI and More: What to Expect from FDA in 2015
Ensure that you’re prepared for FDA’s 2015 plans. Keep your compliance in check with this expert perspective....
Feb 10 2015,
Actions Underway in a Push to Repeal the Medical Device Tax
With support from both major parties, U.S. legislators have introduced bills in renewed attempts to repeal the medical device tax....
Jan 14 2015,
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,