Non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety.
Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable. To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers […]
How do you know if you are pressing the right key, let alone performing the best test?
Focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance.