Case Study: Omniscient Neurotechnology achieves rapid QMS deployment and regulatory compliance with AODocs for Life Sciences

Rapid AODocs QMS Deployment Enables Omni Neuro to Meet Compliance and FDA Submission Requirements

Omniscient Neurotechnology is an early-stage, globally distributed startup that builds brain‑analytics software for neurosurgery and neuroscience. The company needed a scalable, Google‑integrated quality management and document control system to meet strict regulatory requirements (ISO 13485:2016, 21 CFR Part 11 and MDSAP) and to simplify validation across multiple markets, so it selected AODocs and its AODocs for Life Sciences solution.

AODocs delivered a low‑code, quickly configurable QMS and supported custom training and incident‑management workflows, enabling Omniscient Neurotechnology to deploy the system within about a month and use it for an internal audit the following month. With AODocs’ continuous validation approach and support, the company completed both stages of its MDSAP certification, reduced validation effort and internal resource burden, and is using the platform to compile regulatory submissions, including an FDA filing.

Omniscient Neurotechnology

Arie Henken

Director of Quality and Regulatory Affairs