Complete Design Assurance
Our product development process fully complies with the design assurance guidelines outlined in FDA 21 CFR 820, ISO 13485, and adheres to the FDA and European human factors guidelines including HE 75 and ISO 62366. Throughout the product development process, we conduct extensive user needs research, formative testing, and summative testing to minimize use-related hazards and optimize the user's experience.
We integrate specific design assurance activities related to documentation control, traceability, verification and validation, risk management, and usability and human factors throughout the product development process. We create design inputs and outputs for our your design history files (DHF) and device master records (DMR). If you choose, we can take responsibility for documentation control activities, and lead or participate in hazards analysis, failure mode and effects analyses (FMEA), and other risk management activities.