Building a healthcare startup means navigating more than product development. Regulation, clinical validation, reimbursement, procurement and quality management all influence how and when you reach the market. For many founders, this complexity feels overwhelming.
At CO-AX, we help you understand the healthcare landscape early, so regulation becomes part of your growth strategy rather than an obstacle that slows you down.
Regulation isn't the challenge, uncertainty is. Founders spent months, even years figuring out questions around regulatory requirements, whether they need MDR or IVDR, When they need ISO certification and in what cases, Any risks which are good to navigate?
Startups may struggle for too long and still not understand the regulatory landscape. Starting to orientate and structure issues of compliance makes it easier to make confident decisions. Aiming for compliance, from the start, helps avoid costly delays and builds trust with investors, partners, and end users.
Regulation is important at COAX
CO-AX is a healthcare startup accelerator by Sahlgrenska Science Park for founders building healthtech startups within domain of medtech, biotech and deep tech companies.
The healthcare landscape is difficult to navigate alone and understand the requirements often takes a lot. Success depends on clinical evidence, regulatory planning, strategic partnerships and building trust across the healthcare ecosystem.
Our programme is designed with that reality in mind.
You'll receive individual guidance that helps you move forward at the right pace for your company without giving up equity. Since launching the accelerator, we've supported:
155
startups accelerated
8.03
billion SEK raised
9.8
billion SEK market value
653
jobs created
1. Build with the end in mind
Early decision in regulatory plays a significant role for startups. Without it can lead to slower market entry, low competitive advantage, less trust and credibility for investors.
Early intervention in regulatory compliance can prevent future complications and streamline the path to market expansion. Instead of seeing regulation as a barrier, you begin to use it as a guide for building the right product from the start.
CO-AX helps you understand what matters early, without overwhelming you. We work with you on things like product claims, intended use, evidence, documentation, design choices. Good regulatory planning doesn't slow innovation; it helps you avoid rebuilding later.
2. Make complexity manageable
The EU regulatory landscape is comprehensive, But you don’t need to master everything.
Rather than overwhelming founders with every regulation, CO-AX helps you focus on what matters most at each stage of your journey:
What applies to your product
Understand which regulations and standards are relevant to your technology.
What can wait
Avoid spending time and resources on requirements that aren't yet critical.
What to prioritise now
Focus on the actions that will have the biggest impact at your current stage
What comes next
Build a clear roadmap toward validation, certification, and market entry.
3. Compliance that supports growth
Regulation isn’t isolated requirement, it is connected to most things which make impact in a startups journey. Regulatory considerations are crucial for market access and product development. They ensure that products meet safety, efficacy, and quality standards, which is essential for successful commercialization.
Elevyo health entered the CO-AX with general compliance experience but limited clarity around the EU Medical Device Regulation (MDR) through targeted workshops and iterative feedback, we helped the team define a smart regulatory strategy, strengthen their Quality Management System, thereby improve the structure and completeness of their technical documentation.
This hands-on, practical guidance enabled rapid progress from an incomplete foundation to a market-ready product within just a few months, while also supporting broader company development.
As Elevyo health shared, “The feedback was thoughtful, highly relevant, and very actionable by balancing practical advice with scalability, which is perfect for where we are now and where we’re heading.”
Ready to move forward with confidence?
Healthcare innovation will always be complex. You don't have to navigate it alone.
Whether you're preparing your first prototype, planning clinical validation or working toward regulatory approval, CO-AX gives you the expertise, structure and support to make confident decisions at every stage of your journey.
Applications for the next CO-AX cohort open soon.
Join founders who are building healthcare innovations with clarity, confidence and a clear path to market or reach out to us coax@sahlgrenskascinecepark.se