Built for Medical Devices

Accelerate device clearance and approvals, close compliance gaps, and unify quality with product data on one intelligent platform.

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Patient Safety Depends On Product Data Integrity

What is PLM + QMS for medical devices?
Medical device product operations require integrated management of design history, change control, and quality documentation, with traceability from design inputs to commercial release. Audit-ready records at every stage are a regulatory requirement. Propel unifies that product thread, so modern manufacturers can accelerate time to market without compromising compliance.
Regulatory Traceability
Complete, audit-ready traceability across design controls, Design and Development Files, and Medical Device Files gives teams confidence during FDA inspections and premarket submissions.
Closed-Loop Quality
Connecting cases, complaints, CAPAs, and NCMRs directly to affected product records eliminates data silos and accelerates resolution before issues escalate.
Speed to Regulatory Clearance and Approvals
Parallel review workflows and unified product data compress development cycles so teams reach 510(k) clearance and premarket approval without the wait.
How a Unified Platform Accelerates Medical Device Innovation
Propel delivers purpose-built capabilities for medical device manufacturers, connecting engineering, quality, and compliance on one intelligent, cloud-native platform.
Medical Device File (MDF)
Maintain QMSR-compliant Design and Development Files and Medical Device Files with complete revision history and on-demand audit access.
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CAPA
AI-powered CAPA workflows investigate and root-cause issues faster with automated links to complaints, NCMR, SCAR, and supplier records.
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Change Control
ECO workflows with criteria-based approvals keep change cycles tight and traceable across every part and document.
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FDA Digital Submissions
Submit MedWatch 3500A reports electronically via AS2 to FDA ESG, pulling data from complaint and product records to eliminate errors and audit gaps.
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Training Management
Auto-trigger training when documents change versions, along with AI-generated quizzes to keep employees certified and audit-ready.
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Product Registration
Create, track, and renew product registrations across global markets, prevent shipping disruptions, and assess incident impact centrally.
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Surmodics Cut Change Process Time From 278 Days to 73 Days
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Clearing engineering roadblocks
A fully paper-based change and CAPA process requiring five forms and twenty signatures was replaced with a unified PLM/QMS ecosystem on Propel. Surmodics compressed their change cycle by 74% and accelerated change impact assessments by 73% through a phased digital transformation.
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Concept To Customer Solutions for Fast-Moving Product Companies
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 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 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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FAQ
How does Propel support 21 CFR Part 820 and the new FDA QMSR requirements?
How does Propel manage 21 CFR Part 803 MDR reporting for FDA MedWatch electronic submissions?
How quickly can Propel be deployed for a medical device company, and what does implementation look like?
Does Propel support 21 CFR Part 11 electronic records and signatures?
Does Propel include AI capabilities that are safe for regulated medical device environments?
How does Propel support 21 CFR Part 820 and the new FDA QMSR requirements?
Propel QMS supports Design and Development Files and the unified Medical Device File required under the FDA's QMSR, effective February 2, 2026. Propel supports QMSR as well as the traditional DHF/DMR practices. The QMS Validation Accelerator Pack includes pre-built IQ and executed OQ documentation, assessments for Part 11 and GxP, and templates, so teams achieve compliance faster for 21 CFR Part 820 (QMSR), ISO 13485, and EU MDR.
How does Propel manage 21 CFR Part 803 MDR reporting for FDA MedWatch electronic submissions?
Propel's Digital FDA eMDR Submissions feature creates and submits MedWatch Form 3500A reports electronically via AS2 to FDA ESG, gathering data directly from product and quality records. This eliminates double-keying of adverse event data, reduces reporting errors, and maintains a complete audit trail for every submission — all with the push of a button.
How quickly can Propel be deployed for a medical device company, and what does implementation look like?
Deployment timelines vary by scope, but the benchmarks are meaningful. Standard configurations can go live in as little as 4 to 8 weeks. Two factors drive timeline most: how closely your configuration stays to standard (custom workflows take longer) and how clean your data migration is. Propel's implementation approach is structured to move fast while leaving room for the quality process configuration that regulated manufacturers require. Training is also faster than legacy systems — Propel benchmarks at 50% faster new user onboarding compared to legacy platforms. Learn more.
Does Propel support 21 CFR Part 11 electronic records and signatures?
Yes. Propel includes full 21 CFR Part 11 compliance with configurable e-signature controls, automatic user logoff, and a complete audit trail. Pre-built protocol templates covering document control, change orders, and training are included in the QMS Validation Accelerator Pack to accelerate validation effort. Learn more.
Does Propel include AI capabilities that are safe for regulated medical device environments?
Yes, and the compliance-safe design is intentional. Propel One is an agentic AI suite built natively on Salesforce Agentforce and embedded directly into PLM, QMS, and PIM workflows. It delivers task-specific agents that reason on your own product and process data, not a generic model with access to external training sets. Your data is never used to train external AI models. Critically, all AI automation runs inside your existing configurations, permission sets, and business rules, which means it operates within the regulatory guardrails your team has already established and validated. Propel's own research found that 76% of medical device companies are not yet using AI in product operations, largely because of regulatory hesitancy. Propel One is built to address that directly: AI that works within a validated, compliant platform rather than around it. Explore Propel One here.

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