docjo Case Study page

How docjo Passed Their ISO 13485 BSI Audit and tailored their QMS to a Lean, Scalable System

docjo is a Swiss digital health startup transforming chronic care with personalised software that connects patients and healthcare providers.

As they scaled their CE-certified solutions for respiratory and cardiometabolic diseases, they needed a more robust regulatory strategy to support their next stage of growth.

Before

As a fast-moving startup with deep medical and technical expertise, docjo found themselves at a regulatory crossroads:

The company was undergoing strategic restructuring following a spin-off
While they had CE-certified products, their internal Quality Management System (QMS) capabilities were still maturing
The initial BSI ISO 13485 certification audit was on the horizon, adding time pressure to an already lean operation
The team needed clarity on MDR readiness and how to manage compliance in a pragmatic, startup-friendly way
Despite strong motivation, the small team lacked hands-on experience in regulatory execution
Existing resources were generic and ill-fitting - checklists and templates that didn’t reflect their unique setup or constraints

After

Working together with Evoleen Access, docjo achieved a regulatory breakthrough:

Successfully passed their critical ISO 13485 audit leading to their initial certification without any major findings
Adapted their existing out of the box QMS into a lean yet robust QMS tailored specifically to the needs of a small, fast-moving startup
Developed a clear MDR transition strategy that aligned with both regulatory requirements and business goals
Their internal team became more confident and self-sufficient, able to “live the QMS” rather than treat it as a one-off requirement
Gained a regulatory partner who was seen not as an external consultant, but as an extension of the docjo team
Established a solid foundation to launch their asthma product and scale their platform to other indications

“You really adapted to our startup situation. No generic templates - everything was tailored to us. We felt supported and confident going into the audit.” - Oliver Felix, CEO and Co-Founder, docjo

The Process

docjo didn’t just tick boxes - they transformed the way they approached compliance. Here’s how the process unfolded:

Initial assessment of the company’s current regulatory status, product documentation, and QMS setup

Identified gaps related to both the upcoming audit and the longer-term MDR transition

Developed a prioritized action plan focused on the most critical areas, balancing compliance and startup agility

Created or refined documentation with a tailored, fit-for-purpose approach - avoiding one-size-fits-all templates

Worked closely with internal team members to build knowledge and confidence, not dependency

Maintained open, hands-on collaboration throughout the audit prep, with ongoing feedback and iteration

Embedded a “compliance mindset” into daily operations - so that quality and regulation became lived practices, not just requirements

“It just worked - on a personal level and professional level. Trust, pragmatism, and empathy - those qualities are incredibly rare in regulatory consulting.” - Oliver Felix

For a startup like docjo, the road to regulatory success isn’t just about passing an audit - it’s about building sustainable, scalable systems that can evolve with the business.

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