Smarteeva PMS Reporting

Smarteeva PMS Reporting: Every Regulatory Report, One Automated Workflow

Smarteeva generates PSUR, PMSR, HCSR, PMPF-ER, and PMCF-ER reports from a single system. Data is pulled automatically from complaint records, investigation outcomes, external safety databases, and sales data. Business users create and manage customizable templates with their own review, approval, and versioning workflows. AI assists with content drafting. Wave scheduling keeps teams on deadline.

What used to take weeks of manual data assembly now generates in minutes. 8-minute PSUR generation, verified across customer deployments.

What You Will Learn

How automated data aggregation pulls from ERP, complaint handling, and recall databases. How customizable templates work with built-in review and versioning. How AI content generation drafts report sections from live data. How wave scheduling automates reporting cycles with 60-day and 30-day alerts. How product segmentation, jurisdiction mapping, and material grouping organize your reporting portfolio.

Report Types Supported

PSUR (Periodic Safety Update Report) for EU MDR Class IIa/IIb/III. PMSR (Post-Market Surveillance Report) for EU MDR Class I and IVD. HCSR (Health Canada Safety Report) for Class II-IV devices. PMPF-ER (Post-Market Performance Follow-up Evaluation Report). PMCF-ER (Post-Market Clinical Follow-up Evaluation Report). No restriction on the number of custom templates.