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For 41textile, establishing operations and preparing for ISO 13485 certification meant building a quality management system that could scale with the business from the very beginning.
As the newly established company developed its operations, acquired equipment, created procedures, and prepared for internal and certification audits, it needed an eQMS that could be implemented and validated without losing momentum.
Rather than reproducing that manual approach, 41textile retained the strongest existing processes and translated them into a connected digital QMS.
41textile is a Swiss medical device company focused on developing braided textile implants. Its solutions are designed to help address challenges at the interface between soft and hard tissue, such as reconnecting damaged tendons or ligaments to bone.
Because braided structures are soft, flexible, and able to pass through small surgical portals, they offer potential applications across sports medicine, trauma, spinal procedures, and other areas of musculoskeletal care.
41textile began with a small team formed by Niklas Frietsch, Team Leader and Project Manager, Philippe Gédet, Chief Operating Officer, and Michelle Stutz, Chief Technology Officer, with each person working part-time for the company and covering several responsibilities—around 13 to 15 roles between them.
“As we are a small team, we all have to take on several roles. That makes efficiency especially important.”
Michelle Stutz, Chief Technology Officer
Although 41textile was a new company, it could draw on inherited infrastructure, equipment, manufacturing knowledge, and established processes that had already operated within an ISO 13485-certified environment. However, its quality system still relied heavily on Word, Excel, and manual administration.
“Nothing was connected or linked. The system worked, but it was very hard to keep alive. When something changed, it was easy to forget that another document also needed to be updated.”
Philippe Gédet, Chief Operating Officer
Starting from scratch also allowed the team to build a modular QMS around the processes it genuinely needed, with room to expand.
With limited personnel, the team needed a quality system that would reduce administrative work rather than add to it.
Remote access was equally important, as the team worked across locations and could not rely on physical folders or office-based records.
Scilife provided a better fit:
“Scilife gives us the functionality we need to manage our quality processes in one connected system, without introducing unnecessary complexity. It helps us keep our overall QMS lean, focused, and easy to manage.”
Niklas Frietsch, Team Leader and Project Manager
Scilife gave the team a connected environment capable of supporting documents, electronic signatures, Quality Events, CAPAs, Change Control, Audits, and Equipment.
For many medical device companies, software validation can feel like a major obstacle.
41textile wanted to meet regulatory expectations without spending months recreating documentation or repeating testing already completed by the supplier.
The team used Scilife’s validation plan, configuration specification, user acceptance testing protocols, and supporting documentation as its foundation, adapting them to its intended use with only minor changes.
“The documentation took a lot of the validation burden away from us. We were able to focus on validating whether the system worked the way we expected it to work. That meant checking our workflows, approvals, audit trails, and links between items.”
Michelle Stutz, Chief Technology Officer
This created a clear division of responsibility. Scilife provided evidence supporting the platform’s core functionality, while 41textile concentrated on its particular configurations and processes.
For example, the team tested whether:
41textile took a phased, risk-based approach, initially validating the modules needed for launch:
Through advance preparation and close collaboration, the team completed its first validation phase in 16 days. The full scope required around 60 combined hours, with Niklas leading the validation and Philippe and Michelle testing workflows and gathering evidence.
“You can have the best software and the best people, but if they cannot communicate, you cannot move forward. Lean, open communication was a very important part of the process.”
Philippe Gédet, Chief Operating Officer
Today, 41textile uses Scilife extensively as it continues building its QMS. Around 200 documents are already in progress, including SOPs, work instructions, templates, and other controlled documents.
By working together in one system, the team no longer needs to coordinate document versions manually.
“For me, it’s a new world. We can work together in the system without having to worry about versions. The document, its changes, and the audit trail are all there.”
Philippe Gédet, Chief Operating Officer
This centralized history also makes the QMS easier to explain externally, as the team can show each record, its changes, and its audit trail directly in Scilife.
41textile has established a risk-based process for reviewing Scilife updates. Each module and its validated version are recorded in the company’s IT inventory, and every major release, minor release, or bug fix is assessed for impact.
Changes affecting validated functionality trigger targeted revalidation, while bug fixes that don't affect validated functionality require only a documented rationale. This keeps the system’s validated state under control without unnecessary testing.
41textile has already completed the first stage of its internal audit program.
During the audit, the team was able to demonstrate its quality processes directly in Scilife.
Although the auditor had not previously worked with the platform, the system’s structure, traceability, and alignment with established ISO 13485 processes helped build confidence quickly.
“The audit was quite straightforward. We were able to show almost everything in the system, and it did not take long for the auditor to trust it.”
Niklas Frietsch, Team Leader and Project Manager
The internal audit helped the team refine how it explains its digital workflows and identify improvements before the official certification audit.
In future audits, the team will continue to work directly in Scilife, showing SOPs, audit trails, KPIs, Quality Events, CAPAs, changes, and the links between quality records.
When asked what they would recommend to another small medical device company preparing to build and validate its QMS, the 41textile team emphasized preparation and prioritization.
“It is important to know what you need and prioritize it. If you can use the existing validation documentation within your own procedures, you do not necessarily need six months.”
Niklas Frietsch, Team Leader and Project Manager
Niklas also recommends validating the system early. Once the system is validated and in active use, the company can begin building evidence directly within it, demonstrating to future auditors that its processes are not merely documented but actively followed.
41textile has established a strong quality foundation to support both its current operations and future growth.
With five core modules validated in 16 days, approximately 200 documents in progress, and its first internal audit completed, the company is moving toward ISO 13485 certification with confidence.
By choosing Scilife from the outset, 41textile has avoided recreating the manual processes of the past. Instead, it has built a lean, integrated, and scalable QMS that allows a three-person team to work efficiently today and provides room for the company to grow tomorrow.
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