Digital Regulatory Submissions

One Submission Error Can Delay a Device From Reaching Patients

What is Digital Regulatory Submissions?

Digital regulatory submissions is the end-to-end process of preparing, transmitting, and tracking required reports to regulatory agencies, including adverse event filings, product registrations, and compliance documentation, in electronic form. Propel automates this process for fast-moving manufacturers through a unified QMS and PLM platform that connects complaint data directly to FDA MedWatch submissions, global product registrations, and audit-ready records.

Submission Accuracy

When complaint records auto-populate MedWatch 3500A forms via a unified product thread, electronic submissions go out accurate and on time.

Global Registration Control

Maintain, track, and renew product registrations across global markets on a single platform, keeping devices cleared for shipment in every region without lapses.

Audit-Ready Traceability

Every submission, acknowledgement receipt, and linked CAPA lives in a single record, giving teams complete audit history on demand.

Propel Closes the Loop From Complaint to Submission

Automated FDA Reporting

Propel automatically propagates complaint data into the MedWatch Form FDA 3500A and submits it electronically to the FDA ESG via a high-volume AS2 gateway. Acknowledgement receipts are captured with full audit history, eliminating manual data entry and transcription errors across systems.

Reportability Decision Intelligence

Pre-built decision trees determine event severity, required reporting timeframes, and applicable regulatory requirements before a single form is filled out. Teams gain clear, defensible guidance on what to report, when, and to which agency, without relying on tribal knowledge or manual interpretation.

Global Registration Management

Propel tracks, renews, and maintains device registrations and licensing across international markets. Teams get full visibility into registration status across every region so products remain cleared for shipment without last-minute scrambles or inventory disruptions.

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More Capabilities

Reportability Decision Trees

Pre-built decision trees determine event severity and required reporting timeframes for the FDA and other regulatory agencies. Teams get structured, defensible guidance on what to report and when, eliminating guesswork and reducing the risk of missed regulatory deadlines.

Submission Review and Research

Review and filter prior submissions by product line, location, and date range. Leverage historical submission records to prepare corrections, follow-up reports, and pattern analysis, so teams research efficiently and respond to regulators with precision.

Electronic Records and Signatures

Configurable compliance with FDA 21 CFR Part 11 governs user security, audit trails, automatic logoff, and controlled access. Every submission-related record carries a complete, tamper-evident electronic signature history that holds up to scrutiny.

Closed-Loop Case-to-Complaint Management

Connects adverse events to impacted products, components, and suppliers, and ties every resolution back into the same record. Full traceability from issue to CAPA to submission keeps stakeholders aligned and every audit response ready.

Concept To Customer Solutions for Fast-Moving Product Companies

Propel QMS

Complete quality management system that unifies part, process, and supplier quality to deliver safer products, higher customer satisfaction, and increased profits.

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Propel PLM

Cloud-native, role-based, and easy-to-use product lifecycle management enables enterprise-wide collaboration so teams work smarter, faster, and better together.

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Propel One

Natively integrated agentic AI automates workflows, surfaces insights, and accelerates every team across PLM, QMS, and PIM from concept to customer.

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ASP: 6 Quality Applications Consolidated Into 1

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Unified compliance, faster FDA submissions

Advanced Sterilization Products (ASP) replaced six enterprise QMS applications with a single unified PLM and QMS platform, going live in eight months. By connecting complaint records directly to digital FDA MedWatch submissions, ASP eliminated transcription errors and reduced complaint resolution time by 45 days.

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FAQ

How does Propel handle FDA MedWatch 3500A adverse event submissions?

Propel automatically syncs complaint data into the MedWatch 3500A form and transmits it electronically to the FDA ESG via a high-volume AS2 gateway connection. Acknowledgement receipts are captured with full audit history in the same platform. This eliminates manual data entry, reduces transcription errors, and keeps teams compliant with FDA 21 CFR Part 803.

Can Propel support regulatory submissions across international markets?

Yes. Propel's Global Product Registration capability tracks, renews, and maintains device registrations and licensing across global markets, including compliance with EU MDR 2017/745 and Japan's PMD Act. Electronic Instructions for Use are managed by region, country, and language within the same unified platform, eliminating the need for separate localization workflows.

How does Propel support the FDA's QMSR requirements?

The FDA's QMSR, effective February 2, 2026, consolidates legacy DHF, DMR, and DHR documentation into a unified Medical Device File. Propel's eQMS unifies these records under the MDF framework, retaining full change history and audit trails while keeping fast-moving manufacturers aligned with the updated regulatory standard from day one. Explore Propel QMS.

Propel Closes the Loop From Complaint to Submission

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