ALBANY, N.Y., Nov. 2, 2017 /PRNewswire/ -- 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 Minneapolis, Nov. 8-9, in Minneapolis. The exhibit – which will feature capabilities from AMRI's Whitehouse Laboratories and AMRI SSCI – will highlight comprehensive analytical testing capabilities, essential for medical and drug delivery device compliance.
Additionally, AMRI's Wei Zhang, Ph.D., senior research scientist at AMRI, within the extractable/leachables and impurities team, and Frank Bieganousky, director, package and medical device testing, will give a presentation entitled "How to Prepare Your Medical Device Packaging for a Regulatory Submission," 11:15 a.m., Nov. 9, at Center Stage.
"Medical device packaging professionals are familiar with ISO 11607, Parts 1 and 2, but the changing regulatory landscape highlights the upcoming revisions to ISO 10993-18 guideline to further ensure compliance." Dr. Zhang says. "Our presentation will share some of the steps that should be taken when designing and carrying out a package qualification program, including a holistic determination of suitability, safety, and functionality, with focus on the evolving area of extractable/leachable testing."
AMRI continues to expand its expertise and services in order to stay ahead of the regulatory curve on behalf of customers. In July, Whitehouse announced that it had 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 Minneapolis is one of the industry's largest networking opportunities with more than 42,000 medical technology industry professionals from more than 150 countries. AMRI will be featuring a variety of analytical services for medical devices and drug delivery, including but not limited to, container qualification and testing, packaging and distribution testing, medical device and drug delivery testing, extractables/leachables and impurities detection, and microbiology.
To arrange and schedule a meeting with AMRI (Booth No. 1639) while attending MD&M, please make a request here.
About AMRI AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI's team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical and Solid State Services, API Manufacturing and Drug Product. For more information about AMRI, visit www.amriglobal.com.