Medical Device Risk Management

At Kymanox, we provide risk management solutions for medical device compliance with ISO 14971, Medical Device Directive (MDD) 93/42/EEC, and Medical Device Regulations (MDR). We partner with you and your team to develop strategic solutions to address the specific needs of your product. We provide support throughout the product development life cycle including development of a Risk Management File that incorporates risk analysis, hazard analysis, device monitoring, and more.