REVEAL GENOMICS ACHIEVES ISO 13485:2016 CERTIFICATION FOR ITS QUALITY MANAGEMENT SYSTEM

REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation,  proudly announced today that it has been granted ISO 13485:2016 certification for the design, development, manufacture,servicing, installation, and distribution of in vitro diagnostic software providing prognostic and predictive information to guide cancer treatment.

This internationally recognized certification, issued by DEKRA Certification B.V.,confirms that REVEAL GENOMICS’ Quality Management System (QMS) complies with the highest global standards for medical device and in vitro diagnostic software.

The successful audit follows a rigorous two-stage assessment, during which REVEAL GENOMICS demonstrated robust processes, regulatory compliance, and a strong commitment to continuous improvement.

“Achieving ISO 13485 is a key milestone that underscores our dedication to delivering safe, reliable, and clinically meaningful solutions for oncology care,” said Patricia Villagrasa, CEO and Co-Founder of REVEAL GENOMICS.

“This certification strengthens our ability to scale internationally and to meet the stringent requirements of healthcare providers and regulators worldwide. Obtaining ISO 13485 also represents a key prerequisite that paves the way toward achieving the CE mark for our products.”, adds Angeles Sebastian, COO of REVEAL GENOMICS.

Commitment to Quality and Global Expansion

The ISO 13485 certification enhances REVEAL GENOMICS’ ability to:

• Ensure consistent quality, safety, and effectiveness of its diagnostic software.
• Accelerate market access in Europe, North America, and other regulated markets.
• Support partnerships with hospitals, laboratories, and industry stakeholders.

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