Support for in vitro diagnostic (IVD) medical device product development and registration in EU and US

We offer support in the following areas

  • 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
  • Tools - audit ready technical documentation is easily managed by appropriate software tools
    • We offer a slim but effective requirements management and risk management lifecycle solution - tachysDX - specifically adapted to in vitro diagnostic medical devices
    • We are also experienced in the implementation of any other tool available in the market

Requirements and Risk Management Lifecycle Solution for In Vitro Diagnostic Medical Devices

We are looking forward to discuss any opportunity to support your development and registration project.

Get in touch with us!