We design, test and build high-quality products. Aren’t users responsible for their mistakes?
Agilis Answer: The FDA’s short answer is “no.” The FDA sees its regulatory mission is to: o Ensure that manufacturers produce safe and effective medical devices. o Ensure that a safe product includes reasonable protection against dangerous use error. As we work with the FDA and are contributors to its standards and guidelines, we help you understand and anticipate what FDA might be looking from your 510(k) or PMA submission.
