Setting up Regulatory Strategy is crucial to completing the whole project in an efficient way. Therefore we prepare a robust roadmap to define each step, foresee expected time and financial cost and assign their responsible party after evaluating the data and information we get from you through online meetings.
List of standards & regulations for market access
Complying with the regulation and the standards is as important as manufacturing a reliable device. After a customised search for your device, our experienced team provides the most relevant standards and defines the rules to follow in a complex MDR / IVDR regulation. Once we determine the classification of your device according to MDR/IVDR, we can also provide the approximate budget for the whole project. If other regions such as the USA, China, Middle East, Brasil, or India is in your interest, we can provide additional services for registration.
Clinical development preparation
In addition to the regulatory plan, Clinical Plan should be clear, especially for pre-market devices. Clinical plans of devices are developed by a collaboration of our clinical and regulatory consultants in parallel to your regulatory, quality road maps.
Pre-clinical test plan
Preclinical studies are crucial for medical devices to reach to clinical phase. Their primary role is to Show general safety and performance of the devices in the preclinical phase. They also play an important role in CE certification to Show the verification and validation of the device when used as intended. Our experienced scientific affairs team provides you the preclinical test plan specific for your device to Show that the device is safe to go to clinical phase.
