The medical device industry offers enormous innovation potential, from diagnostic equipment to implants, from wearables to surgical robots. But the path from innovation to market is long and costly. AI agents compress this timeline by automating quality processes and reducing the compliance burden.
Regulatory affairs, QMS, and post-market surveillance
- Generating and maintaining technical documentation for MDR/FDA
- Automatically building and maintaining traceability matrices
- QMS procedure monitoring: expiry and review dates
- Non-conformance registration and CAPA workflow automation
Post-market surveillance and R&D support
AI agents automate post-market surveillance by analyzing complaint data for signal detection, monitoring literature updates, generating periodic safety update reports (PSUR), and coordinating vigilance reporting to authorities. For R&D, AI agents automate literature monitoring and generate structured summaries for clinical evaluation teams.
Your Company OS helps MedTech companies implement AI agents that accelerate regulatory documentation, quality management, and post-market surveillance, so more time remains for the innovation that helps patients.
Written by
Chris de Graaf
Co-owner
Has a background in commerce and conversion. At Your Company OS, he helps companies go from meetings and enquiries to concrete, automated follow-up.
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