Key Differences Between USP 1115, USP 1116 and USP 1211
Learn about USP regulations regarding non-sterile and aseptic processes, and sterility assurance and how these relate to regulatory testing requirements.
Learn about USP regulations regarding non-sterile and aseptic processes, and sterility assurance and how these relate to regulatory testing requirements.
Learn how the FDA defines medical devices, 510(k) submission types, and the approximate cost for developing new medical devices.
Learn what isolators are, USP guidelines on isolator systems, and if they are useful in the manufacturing or packaging processes for your medical devices.
Learn techniques for obtaining enough product from inhalant medical device packaging to perform microbiology sampling for regulatory testing.
Learn USP-approved ways to measure and track humidity for medical device sterilization, and relative humidity measurement devices.
Learn the top USP-approved ways to measure temperature for product sterilization and other regulatory tests, and the top measurement devices.
Learn the differences between contract testing and contract manufacturing and how they can both ease medical device manufacturing and regulatory testing.
Learn about sterilization testing and validations and how autoclaves use steam to sterilize medical devices or other medical products.
Learn what sterilization validations are and how to validate steam sterilization processes for your medical device or medical product.
Learn what contract testing is and the benefits of using contract testing organizations to support you with medical device regulatory testing.