Building Quality as a Team Effort – How Klavant prepares for ISO 13485 with MedQdoc
Inossia’s Journey Five Years After Implementing MedQdoc
“Balancing innovation with regulatory compliance requires a structured approach — MedQdoc has enabled us to innovate confidently, knowing our quality and regulatory processes are properly managed and documented.”
Malin Nilsson, CEO, Inossia
Customer Testimonial: Inossia’s Journey with MedQdoc
Inossia is a pioneering Swedish medtech company working at the forefront of healthcare innovation. With breakthrough technologies and a dedicated team, the company is now preparing to launch its first product—a major milestone supported by the right digital tools for quality and compliance. In this testimonial, Malin Nilsson, CEO and Anette Israelsson, Director of QA/RA, share how MedQdoc has helped strengthen their processes, collaboration, and regulatory readiness.
Do you want to read our earlier Inossia case study and learn how Inossia achieved ISO 13485 certification with MedQdoc? Read the full case study here.
Balancing Innovation and Compliance
Leading a medtech company means navigating constant regulatory demands while driving fast-paced innovation. Malin describes this as one of the greatest challenges:
“Navigating the complex regulatory landscape while maintaining our commitment to innovation has been one of the biggest challenges. Financing the journey from idea to product should also not be underestimated.”
Yet she also highlights that the journey has included pleasant surprises:
“The FDA granted Breakthrough Device Designation in June 2025, and the prioritized FDA review pathway exceeded our expectations. The support from our team and stakeholders has been exceptional.”
Note: This illustration shows the Inossia injectable bone cement system, including its primary components and packaging configuration.
Note: The diagram illustrates Inossia’s technology platform, including key system components and their interactions.
Preparing for Growth and Product Launch
Inossia is entering an exciting new phase as their first product approaches market readiness. Malin shares their next steps:
- Launching the company’s first medical device
- Expanding the product portfolio to scale quickly after launch
- Growing the team to meet customer and market needs
- Further developing technologies to improve patient outcomes
“Looking back, implementing a robust quality management system early was one of the most important decisions we made on our journey to market.”
Malin Nilsson, CEO, Inossia
How a medtech innovator continues to balance innovation, regulatory compliance and growth with a structured, paperless eQMS.
Achieving ISO 13485 certification is a major milestone for any medical device company. But what happens after certification? For Inossia, a Swedish medtech innovator, ISO 13485 was not the end of the journey – it marked the beginning of a new phase focused on scaling innovation, preparing for market launch, and navigating both EU, and US regulatory pathways.
Leading innovation in a highly regulated environment
According to Inossia’s CEO, Malin Nilsson, one of the biggest challenges in leading an innovation-driven medtech company is balancing regulatory compliance with the need to stay ahead technologically.
“The regulatory landscape is complex and constantly evolving. Maintaining compliance while continuing to innovate requires a strategic approach and continuous vigilance,” Malin explains. “Financing the journey from idea to product is also challenging and should not be underestimated.”
Unexpected rewards along the regulatory journey
While regulatory work is often perceived as burdensome, Inossia has experienced several positive surprises along the way.
“The support and enthusiasm from our team and stakeholders have been incredibly rewarding,” says Malin. “Seeing our innovations make a real difference in healthcare has been more fulfilling than I initially imagined.”
One particularly positive experience was receiving FDA Breakthrough Device Designation in June 2025. The outcome of the review process was more rewarding than expected.
From certification to growth and market launch
Looking ahead, Inossia is now entering an exciting new phase. The company is preparing to launch its first product on the market – a major milestone after years of development and regulatory preparation.
In parallel, Inossia plans to expand its product portfolio, scale sales after the initial launch phase, and grow the organization to meet customer needs. Continuous development of existing technologies remains a key focus, with the goal of improving patient outcomes and streamlining healthcare processes.
Inossia´s certification journey reflects a structured ISO 13485 QMS implementation process.
Advice to medtech startups preparing for ISO 13485
Based on Inossia’s experience, Malin offers clear advice to other medtech startups preparing for ISO 13485 certification:
“Start early and invest in a robust quality management system. Engage with experts who can guide you through the certification process, and make sure your documentation and processes are thorough and compliant from the beginning.”
“What sets MedQdoc apart is its intuitive interface — everyone in the company can use it, which has improved both efficiency and compliance.”
Anette Israelsson, Director of QA/RA, Inossia
How MedQdoc supports daily quality and regulatory operation
From a quality management perspective, MedQdoc has played a central role in supporting Inossia’s day-to-day Quality and Regulatory compliance work.
Anette Israelsson, responsible for quality management and regulatory compliance operations, explains how MedQdoc has been customized to fit Inossia’s specific needs:
“We have tailored MedQdoc by customizing workflows and templates to align with our quality management and regulatory compliance processes. This ensures efficiency while maintaining full compliance with regulatory requirements.”
Improved efficiency, traceability and audit readiness
Several MedQdoc features have had a particularly strong impact on Inossia’s quality system.
“The document control and audit trail functionality have been especially valuable,” Anette says. “They allow us to track changes clearly and maintain a complete history of our quality processes.”
With previous experience of other document control systems, Anette highlights MedQdoc’s intuitive interface as a key advantage:
“MedQdoc is easy to use for everyone in the organization, which significantly improves efficiency and supports compliance.”
Supporting MDR, QSR and long-term compliance
As Inossia continues its journey, compliance with both EU, US regulations remains a priority.
“MedQdoc provides the tools and documentation support we need to meet MDR and QSR requirements,” Anette explains. “Its comprehensive functionality makes compliance processes more manageable and less time-consuming.”
A scalable eQMS for continuous improvement
When asked what they appreciate most about MedQdoc, both Malin and Anette highlight ease of use, traceability, adaptability and strong customer support.
Beyond tools and technology, Inossia emphasizes the importance of collaboration and continuous improvement.
“Our success is a result of teamwork and strong partnerships,” Malin concludes. “Having an eQMS like MedQdoc in place plays an important role in ensuring we stay compliant as regulations evolve and our organization grows.”
Looking ahead
Inossia’s journey demonstrates that ISO 13485 certification is not a final destination, but a foundation for sustainable growth, innovation and regulatory confidence. With a structured, paperless eQMS, the company is well positioned to scale, launch new products and meet future regulatory challenges.
“MedQdoc’s document control and audit trails have significantly improved our traceability and made regulatory compliance far more manageable.”
Anette Israelsson, Director of QA/RA, Inossia
About Inossia
Inossia is a Swedish medical device company developing innovative healthcare solutions in a highly regulated environment. The company works in accordance with ISO 13485 and supports both EU, MDR and FDA QSR requirements as part of its product development and market preparation.
- Industry: Medical devices
- Focus: Innovative healthcare solutions
- Quality standard: ISO 13485 certified
- Regulatory scope: MDR, QSR (FDA)
- eQMS: MedQdoc
Do you want to read our earlier Inossia case study and learn how Inossia achieved ISO 13485 certification with MedQdoc? Read the full case study here.
Learn more about Inossia at www.inossia.com
Malin Nilsson
CEO & Co-founder
MSc in Materials Engineering and PhD in Experimental Orthopedics, has close to 20 years’ experience in medical devices for the spine and orthopedics industry.
Anette Israelsson
Dir. of QA/RA
Chemical engineer with studies in analytical chemistry from the University of Gothenburg. She has over 25 years of experience in the Medical Device industry in the areas of R&D, Quality, Project Management, and Supply chain.
FAQ – Inossia
1. When did Inossia implement MedQdoc?
Inossia implemented MedQdoc in late 2020 and started using the platform to support its quality management and documentation workflows.
2. When did Inossia receive ISO 13485 certification?
Inossia received its ISO 13485 certificate in 2021, following the implementation of MedQdoc in late 2020.
3. How many users does Inossia have in MedQdoc?
MedQdoc is used across Inossia’s quality and regulatory functions and has been scaled gradually as the organization has grown and prepared for market launch. All employees have a user account in MedQdoc. Initially, Inossia started with five user licenses, which have been expanded as needs evolved.
MedQdoc offers two user types with different pricing models: Ready User and Full User. This allows organizations to scale cost-effectively by assigning access levels based on roles and responsibilities as the organization grows.
Learn more about our pricing options here.
4.How much internal resource support was needed when implementing MedQdoc?
MedQtech provided quality and regulatory expertise during the initial phase, supporting the establishment of the eQMS through a structured setup, hands-on guidance and temporary external QA/RA support.
5. How has the resource need changed over time?
As Inossia has grown, MedQtech’s Senior Quality and Regulatory Advisor has gradually taken on a more limited support role, while MedQdoc has been expanded to support a broader group of users. As Inossia increased its internal team and established in-house quality and regulatory resources, MedQdoc continued to support the organization without requiring a proportional increase in quality administration. The system has helped maintain efficiency while scaling.
6. How does MedQdoc support collaboration across multiple locations?
MedQdoc enables centralized documentation, controlled workflows and clear communication, supporting collaboration between team members working from different sites.
7. Is Inossia using MedQdoc used only for ISO 13485?
No. Inossia uses MedQdoc to support both ISO 13485 as well as ongoing MDR and FDA QSR compliance activities.
Read more about MedQdoc on our Product Page.
8. What regulations apply to Inossia?
Inossia operates in a highly regulated environment and maintains compliance with the following applicable regulations and standards:
-
EU Medical Device Regulation (MDR) – Regulation (EU) 2017/745
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en -
FDA Quality System Regulation (QSR – 21 CFR Part 820)
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 -
General Data Protection Regulation (GDPR) – Regulation (EU) 2016/679
https://gdpr.eu/ -
REACH Regulation – Regulation (EC) No 1907/2006 (as applicable)
https://echa.europa.eu/regulations/reach/understanding-reach
MedQdoc is used across the medical device industry
