ISO 13485:2016 is the international standard for quality management systems in medical device manufacturing. The standard covers everything from design and development to production, supplier management, and post-market surveillance.
For companies producing research-use-only molecular diagnostics solutions, maintaining ISO 13485 certification is voluntary. We've chosen to operate under these standards because the labs we work with need reliable, consistent products. When you're developing laboratory-developed tests or conducting critical research, your supply chain can't be a variable.
For our lab partners, this certification isn't just a plaque on the wall. It's statistical assurance. Studies consistently show that ISO-certified environments operate with significantly higher 'first-pass yields' and lower error rates, ensuring that the reagents reaching your lab perform exactly as expected, batch after batch.
"We're proud of this result because it validates the work our team puts in throughout the year," said Morgan Porter, Chief Operating Officer at Molecular Designs. ISO audits are comprehensive. They examine every aspect of our operations. Zero observations confirm that our quality management systems are performing as designed and our processes are delivering consistent results."
The annual surveillance audit examines our quality management system across all operational areas. Auditors review documentation, observe processes, interview staff, and verify that we're following our established procedures. Zero observations means they found no gaps or areas needing improvement.
This level of scrutiny keeps us sharp. It ensures that what we've documented matches what we actually do, and that our processes deliver consistent results.
Many RUO manufacturers operate under less stringent quality systems. We initially achieved ISO 13485 certification in February 2023 to ensure our PCR panels, extraction systems, and laboratory information systems are manufactured under the same rigorous quality standards as medical devices intended for clinical use.
This gives our clients confidence in product consistency, manufacturing controls, equipment validation, and documented traceability. When labs are building their testing capabilities, these factors matter.
As we expand our product portfolio, these quality standards remain the foundation of our operations. Audits like this one confirm we're maintaining the systems our clients rely on.