It is crucial to understand the regulatory requirements of your IVD product. RegSmart Life Science help you to identify relevant considerations and succeed within regulatory affairs.
There is an important and fair reason for having regulations and standards for Medical Devices, IVD, and Combination Products. It ensures the safety of the patient or the user, and securing the device is making a real difference for the patient. Having this in mind will help your business or project grow.
Understanding the final requirements of the product from the very beginning means that you will be able to set the optimal specifications both on your product as well as on your manufacturing processes and equipment from the start. By doing so, you will for sure avoid costly design changes late in your development process.
Our advisors are experienced in both regulations and numerous standards relevant to the EU and US markets. We also have insight and experience in regulatory affairs for other geographical areas.