At CO-AX, we guide you through four key stages: Orientate, Structure, Execute, and Grow.
This framework allows you to align compliance with your business development strategy, adapting it to your way of working.
"At CO-AX, we don't just meet industry standards; we set them. Our unwavering dedication to compliance and regulatory excellence ensures that every product we manufacture upholds the highest levels of safety, quality, and reliability." - Stefan Book, Business Advisor, CO-AX Accelerator
1. Orientate
This stage begins with a problem or idea and concludes with an assessment and decision to invest time and resources into pursuing a solution or realizing the idea. Key questions to consider include:
What are the unique benefits of our product or solution?
What are the market-specific acceptance criteria?
Which regulations and standards should guide development to ensure quality and acceptance?
2. Structure
Following the decision made in the orientation phase, this stage involves structuring your approach. It ends with a further decision to continue business development. Critical questions at this stage are:
What network of processes will form the foundation of our Quality Management System (QMS)?
What technical documentation is required for regulatory approval?
What will be our Regulatory Pathway and Plan?
3. Execute
Execution begins when structural components are sufficiently clear. While some elements become clearer during this phase, the foundation set in the first two stages ensures a proactive and action-oriented approach. We adapt and refine as needed, drawing from ongoing learning and experience.
4. Grow
Growth emerges from the continuous feedback cycles and experiences gained during execution. It’s about applying, learning, and adapting in an iterative process. The focus here is on results, impact, and how they are achieved. We blend insights from all four stages and refine the QMS as we mature our approach, fostering sustainable business development.
Essential Regulatory Resources for Startups
Understanding and navigating regulatory frameworks is critical for startups developing medical technologies. Whether you're working on a medical device or an in vitro diagnostic (IVD), staying compliant from the start helps avoid costly delays and builds trust with investors, partners, and end users.
Here are key resources to help you get started:
EU MDR (Medical Device Regulation)
A comprehensive guide to the EU Medical Device Regulation (EU MDR), which governs the safety, performance, and market access of medical devices in Europe. Essential for startups bringing hardware or digital health solutions to market.
EU IVDR (In Vitro Diagnostic Regulation)
This resource explains the In Vitro Diagnostic Regulation (EU IVDR), which covers diagnostics, lab testing technologies, and related software. It’s a must-read if your innovation involves detecting, monitoring, or diagnosing medical conditions.
The Swedish Medical Products Agency – Medical Devices
The official regulatory authority in Sweden. This page provides national guidance, regulatory updates, and links to relevant EU frameworks. Especially useful if you're developing or testing your product in the Swedish or Nordic market.
