HemoScreen MDSAP Certification: A Testament to Excellence in Design and Manufacturing

PixCell Medical is proud to announce that its groundbreaking HemoScreen point-of-care Complete Blood Count (CBC) analyzer has successfully achieved certification under the Medical Device Single Audit Program (MDSAP). This milestone further underscores PixCell Medical’s unwavering commitment to the highest standards of quality, safety, and regulatory compliance in the design and production of its innovative diagnostic solutions.

Why MDSAP Certification Matters

MDSAP is a globally recognized program that streamlines regulatory compliance across multiple jurisdictions in participating countries, including the United States (FDA), Canada (Health Canada), Australia (TGA), and the European Union (CE marking under IVDR). This certification reflects PixCell Medical’s dedication to meeting and exceeding the stringent regulatory requirements of these key healthcare markets, ensuring that HemoScreen is manufactured to the highest global standards.

For healthcare providers, MDSAP certification serves as a mark of trust and reliability. It signifies that HemoScreen has undergone rigorous assessment and adheres to comprehensive quality management and safety protocols, reinforcing its status as a best-in-class point-of-care diagnostic device (For more information about MDSAP see here).

Elevating Quality in Point-of-Care Diagnostics

Achieving MDSAP certification is not just a regulatory milestone; it is a reflection of PixCell Medical’s commitment to excellence at every stage of development and production. The certification process involved an in-depth evaluation of HemoScreen’s design, manufacturing processes, risk management, and post-market surveillance systems, ensuring that the device consistently meets the highest safety and performance benchmarks.

HemoScreen’s compact, easy-to-use design, combined with its lab-grade accuracy, has already transformed point-of-care testing by enabling rapid, reliable CBC results in a variety of clinical settings. With MDSAP certification, the device’s superior quality and reliability are further validated, reinforcing PixCell Medical’s role as a leader in advancing hematology diagnostics.

MDSAP certification strengthens PixCell Medical’s ability to provide HemoScreen to healthcare providers in some of the world’s most advanced healthcare systems. As demand for fast, accurate, and user-friendly diagnostic solutions continues to grow, this certification enables PixCell Medical to bring its innovative technology to more clinics, hospitals, and healthcare facilities, ultimately enhancing patient care and clinical decision-making.

At PixCell Medical, we remain dedicated to driving innovation in diagnostic technology and ensuring that healthcare professionals have access to the highest-quality tools for patient management. The MDSAP certification of HemoScreen is a significant milestone on this journey, reaffirming our commitment to quality, compliance, and the future of point-of-care diagnostics.

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