Master Your Sterilization Process
At OMTEC® 2015, Jozef Mastej, Vice President of Operations, Gibraltar Laboratories, Inc. outlined the cleaning and sterilization validation process for...
Aug 11 2015,
Regulations
ISO 9001 Drastically Revised
The ISO 9001:2015 standard is a major revision that will require significant time and resources to determine the best way...
Aug 11 2015,
The Dos and Don’ts of Trademark Registration
The investment of time and money to obtain trademarks may take a significant hit if the respective trademarks are not...
Aug 10 2015,
New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices
FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing...
Jul 01 2015,
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,
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In a recent draft guidance, FDA describes what device companies should consider when submitting OUS clinical data for regulatory approval...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,