In response to evolving industry guidelines, AMRI has assembled a medical device solutions team to help customers navigate the regulatory complexities of developing and testing medical device products. With expertise in biocompatibility, microbiology, toxicology, extractables/leachables, device functionality, packaging/distribution, and container closure integrity testing (CCIT), AMRI’s integrated solutions support medical devices’ entire development lifecycle to meet today’s regulatory expectations of sound science and risk control.
“AMRI recognizes customers’ need for a trusted provider to help interpret these regulatory complexities,” said John Iannone, director, extractables/leachables and impurities, AMRI. “We provide both industry-standard methods for medical device testing and custom protocols for evaluating complex systems. Our scientists have a unique understanding of how analytical chemistry, material science and toxicology merge to meet device safety assessment needs, and participate in the development and writing of the standards and guidelines that drive regulatory requirements.”
For device safety – biocompatibility, chemical characterization and toxicology risk assessment, AMRI participates in the development and writing of important guidelines, including ISO 10993 biocompatibility guidelines, and guides programs to address all aspects of these requirements. This includes cytotoxicity, ethylene oxide residuals, and other in-vitro or in-vivo evaluations through AMRI’s extensive global network of resources. In addition, chemical characterization per ISO 10993-18 is particularly important for combination products, implantable devices, many external communicating devices, and devices that utilize color additives.
In the area of particulate matter analysis and identification, AMRI can provide important investigational data to quickly resolve issues with particle analysis. This can be the first step in developing a root cause analysis.
At AMRI, manufactured devices are tested for microbial contaminants by bioburden and/or endotoxins testing to meet associated regulatory standards, and since reusable medical devices must undergo reprocessing before their next use AMRI can perform both cleaning and disinfection method validations.
To address functional, dimensional, and dose delivery/accuracy requirements, AMRI performs standard and customized testing for drug delivery devices according to ISO 11608, ISO 7886 and other relevant USP and National Standards.
As an International Safe Transit Association and ISO 17025-certified package testing laboratory, AMRI’s dedicated unit for packaging and distribution provides controlled environmental conditioning, accelerated aging, and simulated distribution testing to expose a package system to anticipated environmental and dynamic stresses.
AMRI’s cGMP container closure integrity testing laboratory also offers numerous state-of-the-art solutions to address the unique challenges associated with complex packaging systems, containers, medical devices, and combination products. As a global leader in developing and validating deterministic methods for assessing package integrity per USP 1207, AMRI has provided customers with the successful evaluation of faulty systems, optimization of parameters, and regulatory submission support for the commercialization of their products.