Smart, Intuitive and Compliant QMS Software to Meet Your Regulatory Requirements

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Why Implement an eQMS ?

It is necessary for any organization dedicated to provide safe, compliant, and high quality products particularly in highly regulated sectors such as MedTech industry. easyQ eQMS ensures compliance at any point of time

  • In-built compliance for ISO 13485, FDA 21 CFR Part 820, EU MDR, CDSCO and more, an eQMS eliminates the risk of non-compliance by automating critical quality processes like CAPA, Document Control, Risk Management, and audit trails.
  • Substitutes manual spreadsheets with a cloud-based centralized system that provides real-time version control, effortless collaboration, and instant audit readiness.
  • Whether gearing up for an inspection, scaling across sites, or expanding into global markets, an eQMS increases operational efficiency, maintains data integrity, and enables continuous improvement—making it the smart choice for every MedTech company looking to scale faster and smarter.
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Why Implement easyQ eQMS ?

Supports Global Compliance from Day One

Workflows compliant to ISO 13485, CDSCO, US FDA 21 CFR Part 820 and EU MDR

50% Faster Compliance, Accelerated Market Entry

Reduces the operational burden so your team can focus on product development, market entry, and scaling—not paperwork.

Quick Implementation, Low Setup Effort

Get your QMS in record time with ready to use modules. No long onboarding process or IT dependency. Easy to use without complexicity.

Always Audit Ready, No Last Minute Stress

Be assured with real-time traceability, version control, and digital audit trails with no last minute panic before inspections.

Data Security

Your data is secured with our 21 CFR Part 11 compliant solution to ensure confidentiality and accessibility.

eQMS Features

easyQ Solutions offers a user-friendly eQMS designed for both emerging MedTech startups and established manufacturers
offering faster compliance, hassle free implementation, and effortless scalability
without the complexity of traditional systems.

Quality Policy

Allows your organization to define, monitor and evaluate quality goals that are in line with your quality policy, promoting ongoing development and ensuring compliance with regulatory standards.

Quality Objective

Securely draft, authorize, and communicate your organization’s quality objective and communicate your organization’s quality commitments while making sure they comply with regulatory requirements and seamless integration with key quality procedures.

Responsibility & Authority

To ensure accountability and regulatory compliance, clearly define, document, and maintain clear roles, responsibilities and decision making authority throughout your organization.

Management Review

Simplifies the planning, execution, and documentation of management review meetings to support data driven decision making and maintaining regulatory compliance and quality system standards.

Document Control

Ensure accuracy, traceability, and rigorous adherence to regulatory standards by managing the drafting, review, approval, distribution, and revision of documents efficiently.

CAPA

Centralize problem identification, tracking, documentation and resolution to facilitate in-depth root cause analysis and ensure regulatory compliance.

Training

Simplify the training processes management by monitoring employee development, ensuring regulatory compliance and making the training records and materials easily accessible for continuous improvement.

Risk Management

Inline with ISO 14971, assure efficient Risk Management throughout the product lifecycle by proactively identifying, evaluating, and mitigating risks while adhering to industry standards and regulations.

Complaint Management

Simplify the process of handling complaints so that they can be investigated, documented, and resolved quickly. This will turn complaints into insightful information that can be used to improve products and increase customer satisfaction.

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Pricing

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in action

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