Regulatory Approvals? Now faster and easier.
Health Tech Pathways is yourAI-Powered digital toolkitguiding you step by step through the complex certification process for medical devices. From concept to compliance.
We are in Beta
Why Health Tech Pathways?
Save time, reduce risks, focus on innovation.
We believe that health tech startups can make an impact on patient lives if they’re given the right support.
As a non-profit NGO, we are committed to supporting innovators by providing structured guidance from concept to compliance.
Our regulatory platform offers a transparent, step-by-step pathway towards approval, empowering startups to bring safe, effective solutions to market with confidence.
Navigate the compliance maze with AI assistance
Let us guide you
Tailored identification of regulatory requirements based on product use and risk class
Interactive and personalized roadmap for conformity assessment, including cost analysis
Direct access to a directory of notified bodies and regulatory consultants
AI-driven insights to shape your regulatory strategy
Clarity over chaos - your step-by-step pathway.
We help you clearly articulate your product’s intended medical use, key functionalities, and specifications. This helps determine if your product is considered a medical device under EU MDR 2017/745 and how it should be classified.
Based on the product's risk class and intended purpose, we guide you in selecting the appropriate MDR Conformity Assessment Route. We also help map relevant ISO 13485:2016 requirements and identify which documentation is required for successful certification.
Together, we’ll define a clear, structured list of actions and deliverables, including those needed for the Technical Documentation review by a Notified Body. You’ll also receive tailored references to relevant standards, guidelines, and best practices to streamline documentation and reduce regulatory friction.
We support you in building a realistic project timeline and help you track progress across all compliance activities. You’ll receive tailored references to the most relevant standards, guidelines, and best practices, helping you streamline documentation and meet regulatory requirements with confidence.
Built forHealth Tech startups,scale-ups, andproduct teams.
You don’t need to be a regulatory expert to build safe, compliant products.
Health Tech startups at the MVP or prototype stage
Manufacturers of Class I, IIa, IIb, III medical devices
Teams developing Software as a Medical Device (SaMD)
Supported by afive-year grantfrom the Novo Nordisk Foundation
Supported by a five-year grant from the Novo Nordisk Foundation, we are developing a platform to streamline regulatory challenges and help European health tech startups bring solutions to market faster
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The Foundation’s vision is to improve people’s health and the sustainability of society and the planet. Its mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases, as well as to advance knowledge and solutions to support a green transformation of society.
Tools designed to make your compliance journey smoother, more precise, and faster.