AI/ML Innovations’ NeuralCloud Achieves ISO 13485:2016 Certification

AI/ML Innovations Inc. announced that its subsidiary, NeuralCloud Solutions Inc., has achieved ISO 13485:2016 certification under the Medical Device Single Audit Program (MDSAP). This certification, issued by TÜV USA, Inc., acknowledges the quality management system of NeuralCloud for designing, developing, and distributing its ECG Software as a Medical Device (SaMD) platform.

The ISO 13485 standard is recognized internationally for medical devices, while MDSAP facilitates a single audit across multiple jurisdictions, reducing the audit burden for manufacturers. NeuralCloud’s certification enhances its regulatory readiness, supporting its ECG-focused SaMD technologies like MaxYield™ and CardioYield™.

The MDSAP program aims to streamline quality-system surveillance across varied markets. In Canada, it is mandatory for medical device licenses, while the FDA in the U.S. accepts MDSAP audits in lieu of routine inspections. Despite its benefits, MDSAP does not provide product clearance or marketing authorization.

Paul Duffy, CEO of AIML, emphasized the certification as a testament to the company’s commitment to building regulated infrastructure. This milestone supports NeuralCloud’s strategy to deliver AI-powered cardiac diagnostics globally.