Prostatype Genomics is at the forefront of precision medicine, offering the Prostatype® test—a groundbreaking genetic diagnostic tool designed to assess the aggressiveness of prostate cancer. By providing crucial insights, Prostatype helps clinicians and patients make informed treatment decisions, ultimately improving patient care and optimizing healthcare resources. Prostatype has an ability to significantly improve the quality of life for men subjected to prostate cancer.
The Challenge: A Complex Certification Journey
When the In Vitro Diagnostic Regulation (IVDR) came into effect, it posed a significant challenge for medical device companies across Europe. For Prostatype Genomics, achieving IVDR certification was not only essential for compliance but also a strategic milestone in ensuring continued market access. However, as a small company with a lean team, the responsibility of leading the entire IVDR certification process fell on Katarina Sjöberg, Head of Regulatory Affairs and Quality Assurance, who entered the company after the initial submission of the technical documentation to the notified body. The journey started with inspiring and complex work to respond to the feedback that had just been received from the notified body.
“Leading a company through IVDR certification is a challenge in itself and doing so as the sole RA/QA professional in a small company is something I am incredibly proud of,” says Katarina. “The process required developing extensive technical documentation, interpreting complex regulatory frameworks, and managing all interactions with our notified body.”
A particular challenge was adapting legacy documentation from 2015, which predated IVDR. “The biggest challenge was transforming old documentation to align with the new regulations. Initially, Prostatype had submitted outdated documents, which required significant revisions. We ended up sending over 80 new documents,” Katarina explains.
Additionally, Katarina faced challenge of working with software as a regulated medical device—something she hadn’t done before. “I was very experienced with regulatory processes for reagents, but medical device software as a IVD product was new to me. Understanding the specific documentation and compliance requirements was a major learning curve.”
The Solution: Strategic RA/QA Support from GBA Key2Compliance
Recognizing the complexity of the process, Prostatype Genomics partnered with GBA Key2Compliance, benefiting their long regulatory expertise. The collaboration focused on three key areas:
- Technical Documentation: Ensuring challenging files and records met IVDR and standards, particularly for software compliance.
- Quality Management System Enhancements: Support to strengthen quality compliance for a variation of procedures, to ensure regulatory compliance.
- Strategic Decision-Making: Providing high-level insights on regulatory pathways and validation of key compliance decisions.
“I reached out to GBA Key2Compliance because I needed someone to discuss these challenges with—someone who truly understood the regulations. My colleagues are experts and extremely competent in their respective fields, —especially our CTO, who provided deeper product knowledge— but I needed to work with someone with deeper regulatory experience. I had to make all the decisions myself, and I wanted to ensure they were the right ones. Hence, I have had a very positive experience with GBA Key2Compliance since the 90s, participating in many of their Quality Courses, and that made them my number one choice for this support when I realized it also was possible to get consultant support from them”
Empowering Internal Expertise
Beyond technical support, GBA Key2Compliance played a crucial role in empowering Katarina in her leadership role. The collaborative approach deepened the understanding of regulatory nuances, enabling more confident decision-making.
“The discussions were not about them telling me what to do; instead, we engaged in strategic conversations that validated my thinking and reinforced my decisions. Their expertise helped me recognize my own seniority in this field and realize my own potential, and ability to trust my decisions. That made me strong”
A particularly crucial aspect of their support was around documenting compliance with ISO 62304, a key standard for medical device software. “We didn’t have proper documentation to demonstrate compliance with this standard, and our notified body flagged it as a gap. At the same time that was a new regulation for me. GBA Key2Compliance helped me structure the required documentation, ensuring that we met all necessary requirements. Their guidance made me realize the basic intention of the software specific regulations and standards in many ways are similar to those for reagents. That gave me the competence and confidence I needed to evaluate compliance also for software.”
In addition to compliance, Katarina emphasizes the personal growth and professional development she gained through this process. “Their support and guidance strengthened me in my role and gave me the confidence to navigate complex regulatory decisions.”
The Results: IVDR Certification Achieved
Thanks to thorough planning, hard work, strategic collaboration with both senior support from GBA Key2Compliance and support from our contract manufacturer, Prostatype successfully achieved IVDR certification—a major milestone for the company.
- Strengthened compliance processes and technical documentation.
- Achieved IVDR certification, securing market access and regulatory credibility.
- Validated key regulatory decisions with expert insights from GBA Key2Compliance.
- Empowered internal capabilities, enabling Katarina and the team to manage future regulatory challenges with confidence.
Beyond compliance, the certification has opened new business opportunities. “IVDR certification doesn’t just allow us to sell in Europe—it also supports market access in other regions, where IVDR certification is recognized. More importantly, it signals to stakeholders that Prostatype has a robust regulatory foundation and can be trusted.”
A Testament to Collaboration and Expertise
Prostatype’s journey underscores the importance of strategic partnerships in the MedTech industry. By collaborating with GBA Key2Compliance, they navigated regulatory complexities, transformed challenges into opportunities, and set a foundation for future innovations in prostate cancer diagnostics.
Katarina also reflects on how the process has reshaped Prostatype’s long-term regulatory strategy. “Going forward, we now have a stronger foundation for handling future regulatory requirements. This experience has changed how we approach quality assurance and regulatory compliance—making us more proactive and efficient.”
For companies like Prostatype Genomics, navigating the regulatory landscape can be overwhelming—especially with limited in-house resources. The collaboration with GBA Key2Compliance provided the right level of expertise and strategic collaboration to streamline compliance efforts and achieve certification efficiently.
“If I were to give advice to other MedTech companies embarking on the IVDR journey, it would be this: Find the right regulatory partner. Having an expert by your side makes all the difference in tackling compliance challenges with confidence. GBA Key2Compliance played a significant role in our success. This makes both me and Prostatype Genomics very grateful.” concludes Katarina.
Looking Ahead: Continuing the Partnership
With IVDR certification in place, Prostatype Genomics is now well-positioned to expand its market presence and continue driving innovation in prostate cancer diagnostics. The journey to compliance was not just about meeting regulatory requirements—it was about building a strong foundation for future growth.
Prostatype will continue working with GBA Key2Compliance for future regulatory strategies, internal audits, and ongoing compliance efforts, ensuring sustained success and adherence to evolving regulations.
As for GBA Key2Compliance, this success story is yet another testament to their ability to help MedTech companies navigate complex regulatory challenges with expertise, precision, and a deep understanding of their clients’ needs.
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