Innova Biotech Receives ISO 13485 Certification

Achieving this key quality management standard underscores our commitment to excellence and regulatory compliance.

Achieving this key quality management standard underscores our commitment to excellence and regulatory compliance.

InnovaDx is proud to announce that its manufacturing facilities and quality management system have received ISO 13485:2016 certification. This internationally recognized standard is a critical milestone, demonstrating our robust quality controls and commitment to meeting the highest regulatory requirements for medical device design, development, and manufacturing.

“Achieving ISO 13485 certification is a testament to the dedication and rigor of our entire team,” stated the Head of Quality Assurance. “It formalizes our deep-rooted commitment to quality and provides our partners and customers with the highest level of confidence in the safety, reliability, and performance of our diagnostic solutions. This is a foundational element of our global growth strategy and our promise to deliver products that clinicians can trust.”