Adaptive Designs Provide Clinical Trial Flexibility
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time...
Dec 04 2015,
Regulations
UDI Ruled a Requirement for EHRs
A final rule issued by the Office of the National Coordinator for Health IT of the U.S. Department of Health...
Dec 03 2015,
Harvesting Engineers’ Ideas through Invention Disclosure
The key precursor to the development step is the “harvesting effort.” Answering specific questions allows inventors to organize their thoughts...
Dec 02 2015,
8 Design Control Issues Found During FDA Inspections
Involvement with numerous FDA inspections over the years has given me, I think, a unique perspective on design control trends—specifically,...
Nov 11 2015,
Big Data Tops FDA’s 2016 Priorities
FDA’s Center for Devices and Radiological Health (CDRH) plans to embrace the use of big data and patient reported outcomes...
Nov 10 2015,
3D Printing, Cybersecurity Emerging Concerns for Device Manufacturers
Additive manufacturing and the domination of digital communication and information transfer pose new concerns for manufacturers....
Nov 10 2015,
Manufacturing or Selling Medical Devices in Mexico: A Regulatory Conundrum
Mexico is making significant steps on in-roads into the medical device industry and is ready for success. Industry analysts predict...
Oct 01 2015,
The Fundamentals of a Human Factors Program
Prudent manufacturers already know that the deployment of human factors and usability engineering go beyond meeting regulatory requirements. Manufacturers can...
Oct 01 2015,
Product Development and IP Considerations: A Marriage Made in Heaven?
This article outlines the stages of the R&D process and the corresponding parallel issues that the legal department would want...
Sep 30 2015,
FDA Outlines Critical Quality Measures
FDA’s Director of the Division of Manufacturing and Quality discussed recent Agency initiatives that emphasize quality over compliance....
Sep 11 2015,
CMS Targets Hip and Knee Reimbursement
The U.S. Centers for Medicare & Medicaid Services (CMS) proposed a bundled payments program to accelerate value-based care that, once...
Aug 11 2015,
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,
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,