Entrust Your Medtech Software with Confidence
Senior expertise covering strategy, engineering, compliance, and day-to-day product operations.
Services
Full ownership of your medtech software product. I take responsibility for engineering, maintenance, compliance, documentation, and day-to-day operations, ensuring the system remains stable, auditable, and aligned with standards such as ISO 13485 and ISO 27001. Designed for companies that need continuity and reliability without building a full internal team.
Design and development of new software products in regulated environments. From architecture to implementation, I build systems that are structured for compliance from the start, including traceability, documentation, and quality processes, reducing the cost and risk of meeting regulatory requirements later.
Senior-level guidance for teams building or operating regulated software. I support decision-making across architecture, compliance strategy, quality systems, and product direction, helping you navigate standards like ISO 13485, ISO 27001, and BSI TR-03161 with practical, implementation-focused advice.
Additional engineering capacity for regulated software projects. I contribute directly where needed, and can extend delivery through a trusted network of experienced engineers when appropriate. All work is aligned with compliance requirements and integrated into your existing product and processes.
About
This company is built around one idea: regulated software needs both accountability and efficiency.
I’m a CTO and full stack software engineer with experience in medtech, working on CE-marked patient-facing applications in ISO 13485, ISO 27001, and BSI TR-03161-certified environments.
When you work with me, you get a single accountable partner. I take responsibility for development, compliance, and day-to-day product operations. To support that, I draw on a network of trusted specialists and carefully applied AI-assisted workflows, ensuring continuity and delivering reliable, compliant systems with greater efficiency, without the overhead of a traditional team.
Max Körlinge, Founder
Have Questions? Let's Talk
Send a quick note and I’ll get back within one business day.
You can also send an email to max@maxk.se, or contact me on LinkedIn