Author: Enrica Omiccioli

In the constantly evolving world of in vitro diagnostics, we know that regulatory compliance and quality assurance aren’t just requirements—they’re the fundamental pillars of patient safety and product success. That’s why, at Diatheva, we are proud to have achieved both ISO 13485 and IVDR (In Vitro Diagnostic Regulation 2017/746) certifications. These accomplishments reflect our deep commitment to upholding the highest quality and safety standards for every diagnostic product we create and every process we follow.

Understanding ISO 13485 and IVDR: Our Experience

For us, ISO 13485 is more than just a global standard for quality management systems; it’s the framework that ensures our internal processes, from initial design to final delivery, are carefully controlled and documented.

The IVDR (Regulation 2017/746), which introduced even more specific and detailed requirements for manufacturers like us, was a rigorous challenge we took on directly. We successfully navigated this complex process ourselves, securing both our ISO 13485 quality system certification and the IVDR certification for one of our own diagnostic products (Listeria Test). This direct, first-hand experience gives us a unique perspective on the journey. We meticulously planned every step, engaged with Notified Bodies early, and built a comprehensive roadmap to ensure a smooth submission. The overarching goal of the IVDR—elevating quality standards to ensure safe, reliable, and compliant IVD devices reach patients—is something we’ve embraced completely.

The Value and Implications of Our Certifications

For us, these recent certifications represent a significant step forward. They strengthen our role as a developer and manufacturer of in vitro diagnostic medical devices. When we develop products under the stringent IVDR framework, they are inherently designed to be:

  • Safe: With robust safety protocols integrated throughout their lifecycle.
  • Performance-Monitored: With continuous tracking and evaluation of their clinical performance.
  • Standardized: Adhering to strict international benchmarks for consistency.
  • Controlled: With every stage of production and distribution carefully managed.

 

This commitment to quality gives us and our partners confidence, and it opens up new opportunities for international collaboration with others who share our dedication to high-quality diagnostics.

Extending Our Knowledge: How We Approach IVD Development

The expertise and infrastructure we’ve built to achieve these stringent certifications aren’t just for our own products. We believe our experience can be a valuable resource for other companies looking to bring their diagnostic innovations to market. We don’t just understand the regulatory requirements in theory; we’ve successfully implemented them ourselves, from the initial concept all the way to commercialization.

Our experienced team has gained deep insights through every single phase of this process, and we’re ready to offer an end-to-end perspective on:

  • Design & Feasibility: From the very first spark of an idea, we can help translate concepts into robust diagnostic designs that are inherently compliant and viable.
  • Development & Optimization: We leverage our state-of-the-art facilities and skilled personnel to manage the entire development process, from assay design to prototyping and optimization.
  • Verification & Validation: We meticulously plan and execute all necessary studies, generating the critical data required to prove a device meets its intended performance and safety specifications.
  • Regulatory Documentation Preparation: We can assist in compiling the extensive technical files and quality management system documentation required by regulatory bodies, ensuring accuracy and completeness.
  • Certification Process Insight: Having successfully secured our own IVDR product certification, we possess invaluable first-hand experience in guiding others through the process.

 

At Diatheva, we see these certifications not only as a strategic asset for our own market leadership but as a clear testament to the expertise we can offer other diagnostic companies on their journey to success.

 

Enrica Omiccioli is the Quality Unit & Diagnostics R&D Manager at Diatheva. With a PhD in Biochemical and Pharmacological Methodologies, she leads R&D initiatives for diagnostic kits and assays while managing the quality assurance and control processes, ensuring compliance with the highest standards of excellence.