AMRI, a global contract research, development and manufacturing organization working with the life sciences industry to improve patient outcomes and quality of life for more than 25 years, announced that it will exhibit at MD&M West, February 6-8, 2018, in Anaheim, CA. The exhibit – which will feature capabilities from AMRI’s Whitehouse Laboratories & AMRI SSCI – will highlight comprehensive testing capabilities, essential for medical and drug delivery device compliance.
“Medical device development professionals are seeking guidance in managing the changing regulatory landscape,” said John Iannone, director of Extractables/Leachables & Impurities. “Understanding these requirements early-on has proven to drive a significantly more efficient product development process leading to a successful product release.” During the morning of Thursday, February 8th, 3 SMEs from AMRI will be presenting in a 2 Part Series about some of the steps one should consider while designing and qualifying complex systems, such as combination products. Topics will include Material Selection, Process Optimization, Biocompatibility, CCIT, E&L, Risk Assessment, & Device Functionality. Speakers – Brandon Zurawlow, Frank Bieganousky, & John Iannone – are a part of the AMRI’s comprehensive Medical Device Expert Solutions Team. Our in-depth expertise and extensive portfolio of services provide end-to-end medical device testing and validation solutions to tackle the challenges faced by medical device manufacturers.
AMRI continues to expand its expertise and services in order to stay ahead of the regulatory curve on behalf of customers. In addition to our Expert Solutions Team, Whitehouse announced earlier this year that it had also expanded its drug delivery device testing capabilities to encompass the full series of ISO 80369 standard test procedures, which provides comprehensive evaluations of fittings for medical device and drug delivery systems. With this recent expansion, this facility becomes one of the only facilities in the United States to provide compliance testing services for these standards.
MD&M West connects you with thousands of advanced design and manufacturing professionals for three days of industry immersion. Source from the world’s largest collection of medtech suppliers. Connect with over 20,000 engineers and executives who are ready to forge business partnerships. Learn from industry luminaries presenting their insights. This is your chance to find answers to your current medtech challenges — from prototyping to full-scale manufacturing — while keeping up with the latest innovations reshaping the industry