Expert Services for Medical Device Industry
In Systems Engineering and AI Acceleration Tools
At the forefront of product development, we provide essential tools and guidance for Industry Processes in the Medical Device and IVD Industries. We are particularly dedicated to developing advanced AI based tools for these processes. Our goal is to reduce risk , cost and time to market for products in a regulated environment.
Our Services
Describe important details like price, value, length of service, and why it’s unique. Or use these sections to showcase different key values of your products or services.
You will frequently hear Program and Project Management speak of Risk Management. They almost , always are referring to Project Risk, not Product Risk. Product Risk Management is Crucial to device development, particularly in the Medical Devices Industry, where the Prime Objective is Safety and Efficacy.
While we call out Requirements Management and Risk Management, these exist within a environment of multiple processes and subprocess. They exist across the life cycle of the product from Concept to Withdrawal from the market. The artifacts look different at different stages of the life cycle and there is a very strong integration of Risk Mitigation Strategies and the Requirements that are Risk Controls. We provide the Training in these processes and their integration that was missing in engineering design classes or bioscience classes in school.