We are proud to announce that Aidian has successfully achieved IVDR (In Vitro Diagnostic Regulation) certification, which was granted by notified body TüV SüD Product Service GmbH. This certificate confirms that Aidian complies with the requirements of IVD Regulation 2017/746.
Image Credit: Aidian Oy
This significant milestone highlights our commitment to delivering high-quality, reliable, and safe diagnostic solutions. It is an indication of our dedication to meeting the highest standards of regulatory compliance and ensuring the safety and efficacy of our products. This achievement strengthens our position as a trusted leader in the diagnostics industry.
The implementation of the IVDR requirements to Aidian’s Quality Management System and to products’ technical documentation has been a joint effort between experts from different functions at Aidian. It has required a lot of knowledge and capabilities and is an excellent example of how we work together for a shared goal, the benefit of customer and product safety. We express our heartfelt gratitude to our whole dedicated team and our partners for their support and trust.
With the addition of IVDR QMS certificate, we are committed to continuing to provide high quality IVD products to be used as an aid in diagnostics and making a difference in healthcare.
Stay tuned for more updates and advancements as we continue our journey towards better healthcare.