What We Do
Global Medical Device Quality Systems
What are the requirements to sell a medical device in the EU? What about the United States? What are the latest ever-changing regulations? When will they take effect? Do you know the challenges? We do!! Let us help you to be successful.
Quality Management Systems
Quality Management Systems define business processes that are critical to the success of a product. Having a Quality System that is compliant with requirements but streamlined and efficient can form the foundation of the medical device product life cycle from earliest design through manufacture and post market handling. Not only is a Quality System a global requirement, but the right system facilitates the product development and delivery, thereby providing the framework for success. Our experience with a variety of products allows us to help you choose the right solution for current and future needs as your business grows.
Software Validation
Software quality is a product differentiator. You have one chance to impress customers with the quality of your product. Software failure is not an option for software in a regulated industry. The right development process framework sets the tone for highly successful software products. Efficiently validating the quality and production support software in a risk-based manner meets regulations but is right sized to the impact of that software.