Affinity Biosensors Achieves ISO 13485 Certification, Reinforcing Commitment to Quality and Innovation
June 30, 2023 – Affinity Biosensors is proud to announce that it has achieved ISO 13485:2016 certification through the Medical Device Single Audit Program (MDSAP). This globally harmonized quality standard for medical device manufacturers, now validated through the MDSAP framework, demonstrates our compliance with the regulatory requirements of multiple jurisdictions, including the United States, Canada, Australia, Brazil, and Japan.
Achieving this certification is a major milestone in our growth and reflects our deep commitment to delivering safe, high-quality, and innovative diagnostic solutions to healthcare providers worldwide.
What MDSAP ISO 13485:2016 Means:
MDSAP allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of participating countries. Certification to ISO 13485:2016 under MDSAP indicates that our QMS meets the highest international standards, following a rigorous assessment by an accredited auditing organization recognized across multiple markets.
Impact on Our Company and Our Customers:
For Affinity Biosensors, this certification affirms our operational rigor, product quality, and global regulatory readiness. It enhances our ability to scale manufacturing, enter new markets, and collaborate with healthcare systems and industry partners with greater assurance.
For our customers, MDSAP certification ensures that every diagnostic product we deliver is manufactured under a quality system that meets the strictest international benchmarks. It streamlines regulatory approvals, builds trust in our solutions, and strengthens our mission to improve patient outcomes through precision diagnostics.