Affinity Biosensors Achieves ISO 13485 Certification, Reinforcing Commitment to Quality and Innovation
June 16, 2023 – Affinity Biosensors is proud to announce that it has achieved ISO 13485:2016 certification, a globally recognized quality standard for medical device manufacturing. This certification marks a significant milestone in the company’s growth and underscores its unwavering commitment to delivering safe, reliable, and high-quality diagnostic solutions.
What ISO 13485 Means:
ISO 13485 is the international standard that defines the requirements for a comprehensive quality management system specific to the medical device industry. Certification is awarded only after a rigorous audit process by an accredited body, ensuring that the organization consistently meets customer and regulatory requirements.
Impact on Our Company and Our Customers:
For Affinity Biosensors, this certification validates our operational excellence, product reliability, and regulatory readiness. It positions us to scale our operations, expand into new markets, and partner with healthcare providers and industry leaders with increased confidence.
For our customers, ISO 13485 certification ensures that our diagnostic products are manufactured to the highest standards of quality and compliance. It strengthens trust in our technology, supports smoother regulatory approvals, and reinforces our dedication to improving patient outcomes through innovation.
“This milestone is not just a reflection of our quality systems—it’s a testament to our team’s dedication to building life-changing diagnostic tools with precision and care,” said Ken Babcock, CEO of Affinity Biosensors. “Our customers can be confident that we are prepared to meet the highest expectations, now and in the future.”