Complear is a regulatory support company expert in Digital Health, Software as Medical Device and AI as Medical Device.
Description of the structure
Expertise(s) of my company
We can support ensuring regulatory compliance with Medical Device and Cybersecurity requirements for market access in the EU, UK, Switzerland, and US.
We are working on the EU and US industry developments in this field among global industry-leading organizations, such as EIT Health, Dime Society (where we are launching a global project to map Digital Health regulations around the world with companies like Google), and TOPRA (the Regulatory Affairs Professionals association, where we lead the Software group and discussion topics). As a field in constant move, our team is part of the most updated discussions on new standards, regulations, and access to the different stakeholders across EU and the US.
Areas of cooperation sought
We can support giving access to training materials, templates of documentation, regulatory guidance, support on defining regulatory strategy for a project.