Worldwide, strict regulations define the conditions under which medical devices may be placed on the market. From product development through manufacturing to market launch and post-market surveillance (PMS), companies must meet a wide range of requirements. These requirements are extensive and complex, governed by the Medical Device Regulation (Regulation (EU) 2017/745, MDR) as well as country-specific regulations such as MepV (Switzerland), FDA (USA), TGA (Australia), HC (Canada), NMPA (China), PMDA (Japan), and many others.With our Regulatory Affairs team, you have a partner at your side who knows the requirements for international market approval in detail. Together, we develop the optimal approval strategy for your product and target market – and we provide crucial support to ensure that your product obtains approval in your market as quickly as possible.Get to know us in a non-binding introductory meeting. The international approval of medical devices is complex – but it also offers great potential for optimization through a strategic approach.
Market entry? Strictly regulated.
We know these rules inside out. Try us out!
