Compliance and quality are paramount in the medical device industry. Our experts guide you through the design control process (ISO 13485), implement rigorous product risk management (ISO 14971), and develop verification plans, protocols, and reports with statistical rationales. We conduct thorough lab and pre-clinical testing, usability testing, and follow up on clinical data, ensuring the safety and effectiveness of your medical devices. Our team also assesses product risks and implements initiatives to reduce and minimize potential risks.