Klavant is a Germany-based medical technology company focused on innovative cardiac solutions. With upcoming ISO 13485 Stage I and Stage II audits, Klavant has taken a deliberate approach to build a quality management system that supports both compliance and collaboration.

Right from the start, Klavant chose to work almost fully digital and selected MedQdoc as the foundation for their eQMS. This decision was driven by the ambition to build a quality system that supports both regulatory compliance and day-to-day collaboration.

For Klavant’s Chief Quality Officer, quality is more than a regulatory requirement. It is about creating an environment where teams understand what they need to do, why they do it, and how quality contributes to the product.

This approach ensured that quality processes were not only documented, but actively used and understood across the organization.

Why Klavant chose a fully digital QMS

Klavant decided to start almost fully digital from the beginning, as this was the most logical approach for a modern medical device company operating in a regulated environment.

A digital QMS provides clear structures, transparency, and reliable version control across the organization. Instead of treating traceability as an abstract regulatory requirement, Klavant wanted a system where traceability is understandable, accessible, and naturally integrated into the QMS.

Based on previous experiences, it was important for Klavant to choose an eQMS that is intuitive, well structured, and truly supports regulated processes — not only for quality management, but across the entire organization.

The benefits of a digital eQMS in daily work

A fully digital eQMS supports both flexibility and efficiency in daily work, especially in modern and geographically distributed teams. Digital workflows reduce dependencies on physical presence and manual document handling, enabling teams to work more confidently and efficiently.

Key benefits highlighted by Klavant

When the Klavant team summarized the key benefits of working with a digital eQMS, the following points were highlighted:

• End-to-end digital document lifecycle supporting daily work
• Real-time visibility across the quality system
• Seamless collaboration between different teams
• Fast access to controlled documents without manual searching
• Greater confidence that everyone works with the latest approved version

Preparing for ISO 13485, MDR – and beyond

The onboarding and transfer of the existing QMS to MedQdoc was structured and collaborative. Time was taken to guide Klavant through the system and adapt it to their specific needs, making it easier for the team to get started without requiring additional internal resources.

As a medical device company, Klavant is preparing to comply with ISO 13485 and EU MDR requirements. It was therefore essential to choose a system that not only supports certification activities, but also provides structured support for technical documentation throughout the entire product lifecycle. This gives Klavant a quality and regulatory documentation foundation that supports both current certification needs and future regulatory requirements.

A strong partnership

Beyond the system itself, Klavant highlights the collaboration with the MedQdoc team as an important factor. Ongoing guidance, regulatory best-practice support, and responsive communication contribute to confidence as Klavant prepares for upcoming audits.

Looking ahead

As Klavant approaches their upcoming ISO 13485 Stage I and Stage II audits, the focus remains clear: quality is not just about documentation, but about mindset, collaboration, and ownership.

With MedQdoc, Klavant has created an environment where both quality and technical teams are supported — enabling motivation, engagement, and quality to be reflected in the product itself.

We wish Klavant the best of luck in their upcoming ISO 13485 audits.