Medical device regulations in the United States and in Europe are continuously updated to reflect a deeper understanding of patient risk. These updates often require the development of new test plans and approaches. The new regulations are further complicated by the changing interpretation of standards, as regulatory bodies refine their positions in response to new information. At Cambridge Polymer Group, our scientists are integral to clients’ regulatory submission teams and actively contribute to standards development for material testing and biocompatibility assessments. By regularly attending workshops and conferences, they stay informed about the latest developments and best practices in regulatory testing. This expertise, coupled with our underlying decades of experience in polymers and medical devices, enables us to effectively support our clients’ regulatory needs.
Biocompatibility Testing
Biocompatibility assessment is required for medical devices per ISO 10993-1. This standard is currently undergoing revision, requiring companies to familiarize themselves with the required changes for their regulatory submission. A comprehensive regulatory submission includes selecting the appropriate biocompatibility tests, developing a biological evaluation plan to guide these tests, and compiling the results into a biological evaluation report. Understanding polymeric materials and selecting the right biocompatibility tests is crucial for a cost-effective regulatory strategy. This is because the unique characteristics of polymeric materials demand specialized knowledge to design effective tests and accurately interpret the results.
Cleanliness Testing
Clean line validation and routine cleanliness testing requires experience with analytical analysis of extracts, according to ASTM and ISO standards. Our scientists at Cambridge Polymer Group have played a significant role in drafting many of these standards and provide valuable assistance to clients in their validation and verification processes.
Extractables and Leachables
Identification and quantitation of chemicals that elute during storage or clinical use is regulated for medical devices and pharmaceutical products through ISO 10993-18 and USP <1663>–<1665>. Conducting these tests requires detailed knowledge of materials, high resolution analytical testing, and a deep familiarity with the regulatory environment. As recognized experts in the field, thought leaders from Cambridge Polymer Group frequently share insights on best practices in extractables and leachables studies.
Regulatory Gap Analysis
A regulatory gap analysis is a comprehensive assessment that identifies what information is missing from a regulatory submission, ensuring compliance with relevant standards or guidance. This analysis is typically performed when preparing a new submission for a modified device that has already been approved, or for a new device with partially completed testing. The analysis may also involve leveraging data from predicate devices and incorporating published safety information about materials used in the device, providing a strategic approach to regulatory compliance.
Regulatory Submissions
A regulatory submission should include a risk management plan, as specified by ISO 14971, which addresses the risks presented by the material and chemical constituents of a device, as outlined by ISO 10993-1. This plan should also encompass aging studies, design verification, and failure modes analysis. At Cambridge Polymer Group, our team collaborates closely with clients to develop and execute regulatory plans for polymer-based medical products, ensuring a thorough and effective approach to regulatory compliance.
Material Stability Testing
Polymeric materials should undergo stability testing for both shelf-storage and their intended clinical application, where feasible. Given the unique properties of polymers, careful consideration is essential when designing accelerated aging protocols. Accelerated aging tests, such as those specified in ASTM F1980, are commonly conducted on devices. Additionally, oxidative challenge techniques, as outlined in ASTM F2003, F3336, or ISO 10993-13, are also frequently used. Selection of the appropriate techniques requires knowledge of the material’s degradation behavior and the intended environment and final use. For medical devices, testing may involve simulating exposure to various biological environments, including blood, dental soils, stomach fluid, and lipid-rich environments.
Accelerated Aging
Manufacturers of products often need to establish shelf-lives for their products, which dictate how long a product can sit in its packaging on the shelf before it needs to be disposed of or requalified. Accelerated aging studies make use of conditions that hasten potential degradation processes so that real-time aging studies can be minimized.