Effective project management, tying together your internal organization, development partners, suppliers, Notified Bodies, and regulatory agencies
We provide the development resources providing you with flexibility in a changing environment or ramp-up phase
With our diverse background (IVD, medical devices, combination products and biopharmaceuticals) we are uniquely positioned to help you navigate the challenges of highly regulated industries
We support your transition to ISO 13485:2016
We support your transition from IVDD 98/79/EC to IVDR 2017/746
We establish technical documentation under your established processes
We develop registration strategies for your new product, or for expanding to new markets
We audit and manage your suppliers and establish seamless processes tying into your quality system