Smarteeva

Smarteeva automates MedWatch, MDR, EU PSUR, PMSR, and global regulatory submissions, generating reports in minutes. Stop assembling data manually.

Automate PMS from complaint intake to PSUR. ISO 13485 and EU MDR ready, Salesforce-native, with AI extraction at 96% first-pass accuracy.

Built for quality leaders in medical devices. Complaint and CAPA oversight, audit-ready records and post-market metrics in one Salesforce-native platform.

Smarteeva provides Salesforce-native quality management for medical devices, covering complaints, adverse events, PMS reporting, and recalls.

The article describes five patterns that distinguish AI used in production from AI used in marketing for MedTech post-market surveillance. It says many vendors promote AI features that do not change how work gets done.

Industry analysis, product updates, and practical guides for medical device quality and regulatory teams. Written by the PMS experts behind 35% of FDA MDR filings

The article compares eQMS software with purpose-built post-market surveillance platforms. It says eQMS systems handle SOPs, training records, design controls, and audit management, and also claim to handle complaints.

The article compares manual and automated PMS reporting workflows step by step and examines where 100+ hours of manual report assembly time go.

Purpose-built AI platform for medical device post-market surveillance. Trusted by 450+ MedTech companies. MDR submissions in 3 minutes, PSURs in 8.

Smarteeva offers AI-powered post-market surveillance solutions and has offices in the US, Europe, and Asia.

Enterprise post-market surveillance for medical devices. AI-powered complaint management, adverse event reporting & regulatory submissions. Salesforce-native.