Medical Device Patient Data Consent Form

Medical Device Patient Data Consent Form Template

Managing patient consent for medical device data collection is a critical compliance requirement for device manufacturers and healthcare providers. This Medical Device Patient Data Consent Form template helps you collect explicit, documented permission from patients for device usage data, health outcomes tracking, adverse event monitoring, and product improvement research—all while maintaining regulatory compliance and protecting patient privacy.

Why medical device companies need robust data consent forms

Medical device manufacturers face unique challenges when collecting patient data. Whether you're tracking pacemaker performance, monitoring insulin pump usage, or gathering outcomes data from orthopedic implants, you need clear, documented consent that meets FDA, HIPAA, and international regulatory requirements. This template provides a structured approach to obtaining informed consent that protects both your organization and your patients.

This form covers the essential elements of medical device data consent: clear explanation of what data is collected, how it will be used, who will have access, how long it will be stored, and how patients can withdraw consent. It also addresses specific use cases like adverse event reporting, long-term outcomes tracking, and product safety research.

Key features for medical device patient consent

The template includes dedicated sections for:

• Patient and device information – Capture essential identifying information and specific device details
• Data collection scope – Clear explanation of device usage data, health outcomes, and monitoring parameters
• Purpose and use cases – Transparent disclosure of how data supports safety monitoring, research, and product improvement
• Privacy and security – Information about data protection measures, storage, and access controls
• Rights and withdrawal – Clear process for patients to withdraw consent or request data deletion
• Adverse event reporting – Specific consent for safety monitoring and regulatory reporting
• Research participation – Optional consent for involvement in product improvement studies
• Electronic signature – Legally binding digital consent capture

Who benefits from this template

This form template is designed for:

• Medical device manufacturers collecting real-world evidence and post-market surveillance data
• Healthcare providers using connected medical devices and digital health platforms
• Clinical research organizations conducting device performance studies
• Digital health companies developing patient-facing medical device applications
• Hospital systems implementing remote patient monitoring programs
• Medical device regulatory teams ensuring compliance with FDA, EMA, and other regulatory requirements

Streamline consent management with Paperform

Built on Paperform, this template offers professional consent collection with the flexibility to match your brand guidelines. The document-style editor lets you customize language to meet specific device requirements or regional regulations, while maintaining a clear, patient-friendly format that builds trust.

With conditional logic, you can tailor the form based on device type, patient age, or research participation—showing only relevant sections to each patient. Electronic signatures through Papersign (papersign.com) provide legally binding consent with full audit trails, essential for regulatory submissions and compliance documentation.

The form integrates seamlessly with your existing systems. Send consent data to your CRM, patient management system, or data warehouse through direct integrations or Stepper (stepper.io) workflows. Automatically trigger follow-up emails, update patient records, or route completed consents to compliance teams for review and archival.

Maintain compliance and build patient trust

Transparent data consent isn't just a regulatory checkbox—it's fundamental to building patient trust in connected medical devices. When patients understand how their data will be used to improve device safety and performance, they're more likely to engage with monitoring programs and provide valuable real-world feedback.

This template helps you meet regulatory expectations while creating a positive patient experience. The clear, jargon-free language explains complex data practices in accessible terms, and the structured format ensures no critical consent element is overlooked.

Paperform's security features support your compliance requirements with SOC 2 Type II certification, data encryption, and configurable data residency controls. Role-based permissions let you control who can access sensitive consent records, and detailed submission logs provide the audit trail needed for regulatory inspections.

Automate consent workflows with Stepper

Once a patient submits their consent form, Stepper (stepper.io) can automate your entire consent management workflow. Automatically send signed consent forms to patients via email, update your device registry with consent status, create tasks for clinical coordinators to schedule device training, and trigger alerts when consent is due for renewal.

For organizations managing multiple devices or research programs, Stepper workflows can route consent forms to appropriate teams based on device type, automatically extract key dates for retention compliance, and maintain a centralized consent database across multiple systems—all without custom development.

Build better medical devices through informed participation

Every great medical device improvement starts with real-world patient data. This consent form template makes it easy to build a compliant, scalable program for collecting the insights you need to enhance device safety, optimize performance, and develop next-generation features.

Whether you're a startup launching your first connected device or an established manufacturer expanding your post-market surveillance program, Paperform provides the flexible, secure platform you need to collect patient consent professionally and compliantly.

Get started today: Customize this template to match your device specifications and regulatory requirements, embed it in your patient portal or send it directly to patients, and start building a consent program that supports both safety monitoring and innovation.