Amphastar Pharmaceuticals, Inc. established a device laboratory in 2018. As 21 CFR 820 and ISO 13485 requires risk management and analysis applied over the total product life cycle, ISO 13485 looks to ISO 14971 for guidance. The device lab is dedicated to medical device deign and development for the Company's combination products while strictly following the FDA and ISO requirements.
Literature searches, patent screening, predicate device review, user needs analysis, and complaint review begins in the inception stage. This is followed by concept development, where different scenarios are evaluated, and prototypes are created to complete the product design as the design input. Next, design output is generated by fulfilling product development, product testing, usability functionality testing, and simulations. The design output is verified by rigorous testing during design verification and validation and the user needs are validated. Design transfer is performed and finalized before regulatory submission.
Our combination products, such as pre-filled syringes, injection pens, intranasal devices, MDI, and DPI, are displayed below.