As Archem Diagnostics, we have successfully achieved a major milestone on our journey toward full compliance with IVDR (EU) 2017/746, the most current and stringent regulation in the in-vitro diagnostics industry.
In order to formally validate the high quality standards and clinical performance of our products, we have entered into a long-term strategic agreement with an internationally recognized Notified Body, covering our CE certification processes.
This collaboration represents a strong commitment that the diagnostic kits and devices manufactured by Archem meet the highest levels defined by global authorities in terms of patient safety, clinical evidence, and performance evaluation. Our partnership not only ensures regulatory compliance for our existing product portfolio, but also guarantees that next-generation projects developed at our R&D Center will reach global markets in the safest and most efficient manner.
We are transforming this regulatory transition within our industry into a value proposition based on trust, continuity, and transparency for our global partners and customers. As Archem Diagnostics, we will continue to ensure sustainability in diagnostic quality through our world-class manufacturing discipline and to add lasting value to the future of healthcare.
We sincerely thank all our stakeholders and healthcare professionals who place their trust in us.