eQMS Solution for Medical Devices 

Streamline Compliance. Enhance Quality. Accelerate Market Access.

Medical device manufacturers operate in a highly regulated environment, requiring robust quality management systems to ensure product safety, regulatory compliance, and operational efficiency. ReMediate eQMS is an advanced electronic Quality Management System (eQMS) designed specifically for the medical device industry, ensuring seamless compliance with:

✔ 21 CFR Part 11 – Electronic Records & Electronic Signatures Compliance
✔ ISO 13485:2016 – Medical Device Quality Management System
✔ EU MDR (2017/745) & IVDR (2017/746) Compliance
✔ FDA QSR (21 CFR Part 820), MDSAP & Global Regulatory Standards

With ReMediate eQMS, medical device companies can digitize quality processes, enhance traceability, automate compliance, and accelerate regulatory approvals.

Why Choose ReMediate eQMS for Medical Device Quality Management?

🔹 100% Regulatory Compliance – Meets all FDA, ISO, and EU MDR requirements.
🔹 Cloud-Based & Scalable – Secure, GxP-compliant cloud infrastructure.
🔹 Fully Validated System – Pre-configured for ISO 13485, 21 CFR Part 11 compliance.
🔹 Electronic Signatures & Audit Trails – Full data integrity & traceability.
🔹 AI-Powered Automation – Reduces manual effort & human errors.
🔹 Seamless Integration – Connects with ERP, PLM, LIMS, and other enterprise systems.

Key Features of ReMediate eQMS

✅ Document Control & 21 CFR Part 11 Compliance

• Centralized document management with version control.

• Electronic signatures (FDA 21 CFR Part 11-compliant).

• Automatic audit trails and access control for full traceability.

• Secure cloud storage with role-based permissions.

✅ CAPA (Corrective and Preventive Actions) & Nonconformance Management

• Automated CAPA workflows with root cause analysis tools.

• Risk-based CAPA prioritization aligned with ISO 14971 risk management.

• Integrated NC (Nonconformance) tracking & escalation.

• AI-powered CAPA effectiveness monitoring.

✅ Training Management & Employee Compliance

• Automated training assignment & tracking.

• Ensures employee competency per ISO 13485 & FDA QSR requirements.

• Digital training records & compliance reporting.

✅ Design Controls & Product Lifecycle Management (PLM)

• Supports Design History File (DHF) & Design Master Records (DMR).

• Integrated risk management per ISO 14971.

• Version-controlled design reviews & approvals.

✅ Supplier & Audit Management

• Vendor qualification & supplier audits per ISO 13485 & FDA QSR.

• Automated supplier scorecards for performance tracking.

• Centralized audit scheduling & findings resolution tracking.

✅ Complaint Handling & Post-Market Surveillance (PMS)

• Fully compliant with FDA MDR (21 CFR Part 803) & EU MDR vigilance reporting.

• Automated complaint escalation & investigation tracking.

• Field Safety Corrective Actions (FSCA) & recall management.

✅ Change Control & Quality Event Management

• Automated engineering change orders (ECO) & deviation approvals.

• Risk-based impact assessment for regulatory compliance.

• Ensures seamless collaboration between teams & suppliers.

✅ Risk Management (ISO 14971 & EU MDR Compliance)

• Risk analysis, evaluation & mitigation tracking.

• Fully integrated with CAPA & post-market surveillance modules.

• Supports Failure Mode and Effects Analysis (FMEA).

✅ Audit-Ready Reports & Dashboards

• Real-time compliance dashboards & KPI tracking.

• Pre-built templates for FDA, ISO 13485, and Notified Body audits.

• Automated regulatory submission reports.

Built for Medical Device Startups, SMEs & Enterprises

Whether you are a startup, small manufacturer, or a multinational MedTech enterprise, ReMediate eQMS offers customizable solutions that scale with your business.

For Startups & SMEs:
✔ Pre-configured templates for rapid implementation.
✔ Cost-effective cloud deployment.
✔ Regulatory guidance to streamline compliance.

For Large Enterprises:
✔ Scalable architecture with multi-site support.
✔ Advanced AI & automation for efficiency.
✔ Enterprise-grade integrations (ERP, LIMS, PLM, MES, etc.).

21 CFR Part 11 Compliance – Ensuring Data Integrity & Security

ReMediate eQMS ensures full compliance with FDA’s 21 CFR Part 11 for electronic records and signatures, providing:

✔ Secure electronic signatures (FDA-compliant).
✔ Tamper-proof audit trails & timestamped logs.
✔ Data encryption & role-based access control.
✔ System validation & GxP compliance for FDA-regulated environments.

Seamless Integration with Your Existing Systems

ReMediate eQMS integrates with:

🔗 Enterprise Resource Planning (ERP) Systems – SAP, Oracle, NetSuite.
🔗 Product Lifecycle Management (PLM) Systems – Windchill, Arena, Siemens Teamcenter.
🔗 Manufacturing Execution Systems (MES) – Rockwell, Siemens, GE Digital.
🔗 Laboratory Information Management Systems (LIMS) – STARLIMS, LabWare.
🔗 Electronic Batch Records (EBR) & Regulatory Submission Tools.

Why ReMediate eQMS is the Best Choice for Medical Device Companies

✔ 100% Compliance with ISO 13485 & FDA QSR – Reduces regulatory risk.
✔ AI-Driven Automation – Saves time & boosts efficiency.
✔ Real-Time Collaboration – Improves team communication.
✔ Pre-Validated & Pre-Configured – Faster implementation & deployment.
✔ Seamless Audit Readiness – Stay inspection-ready at all times.

Transform Your Quality Management with ReMediate eQMS

ReMediate eQMS empowers medical device companies to eliminate paper-based systems, streamline compliance, and accelerate market approvals. Whether you are preparing for an FDA audit, achieving ISO 13485 certification, or ensuring EU MDR compliance, ReMediate eQMS is your trusted digital quality partner.

📩 Get a Demo Today!

📧 Email us at info@imdrmedtech.com to learn more about ReMediate eQMS!