Medical Devices: The importance of chemical and material characterization
Evolving regulations are dramatically changing the medical device industry.
Whether increasing efficacy and reliability, reducing manufacturing costs, or delivering the highly personalized devices of the future, the medical devices industry depends on materials science to deliver products that are fit for their intended use and that also meet both regulatory and performance requirements.
As new regulatory requirements are introduced, adopting a more thorough approach to chemical and material characterization can be the essential ingredient in securing a first-to-market advantage. Our new eBook titled Medical Devices Regulatory Pathway: The Importance of Chemical and Material Characterization offers critical insight into the changing regulatory environment and the growing requirements for chemical and material characterization testing. Download your free copy of the eBook to learn more about how the changing regulatory dynamics will impact the medical device industry.
A greater need for understanding of chemical, material, and complete device performance
In response to a continued focus on materials innovation, newly modified regulations place specific emphasis on chemical testing, such as extractables and leachables as described under ISO 10993. The combined focus on both chemical analysis and material property testing, together with support the critical nature of ensuring product efficacy and patient safety.
In helping manufacturers achieve a more robust level of compliance that is aligned with today’s materials advancements, regulators across Europe are updating three decades of regulatory history by replacing a series of existing medical device directives with a more comprehensive set of regulatory guidelines captured under the European Medical Device Regulations (EU MDR). Through the introduction of the EU MDR, regulators are aiming to strike a better balance between the risk associated with medical devices and their benefit to society.
Manufacturers with a robust understanding of the regulatory impact of inputs across the medical device supply chain will be rewarded faster and smoother approvals around the globe.
Identify and assess the risk associated with chemicals used in the design and manufacturing of medical devices through testing of harmful leachables.
Understanding of material physical property and performance characteristics that support key safety, strength, impact resistance, and other desired qualities.
Learn how durability testing is used to ensure medical devices do not fail unintentionally or prematurely under physiologic loading conditions.
Device innovation and approval is hard work, finding the right tools shouldn’t be. Contact us today to learn how we can help you accurately and efficiently gain insight into the chemical structure and physical property performance of your medical devices.