Biocompatibility testing is a regulatory safety requirement that assures a device and its components are compatible with the biologic environment in which the device will be used. Maintain your critical path to market with these tips.
Under the FDA and other regulatory bodies, the bio/pharma and medical device industries have been using computer software/systems validation testing methodologies to validate software within the GxP environment. Let's dive into the use of Agile methodology in the planning phase of a software development plan.
