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Medical Device Testing Services

End-to-End Verification & Validation of Advanced Medical Devices for Dental, Surgical, Cardiac, Orthopedic & Diagnostic Excellence

IoT Assurance improves automation coverage by 50%

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Increase release capacity by 30%, reduce deployment costs by 85%

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Maximize Medical Device Quality with Our Next-Gen Digital Assurance Solutions

Our Key Clients

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toyota
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Driving Excellence in Medical Device Testing Through Smart Automation.

Top 10 Best Practices for Effective Software Testing in Medical Devices.

Transforming Diabetes Management with Advanced Device Software & Innovative Health Tech.

Medical Devices Testing services

Medical devices play a vital role in shaping the future of patient care, where safety, precision, and compliance are non-negotiable. At AMZ, we empower leading Medical Device manufacturers with end-to-end software testing solutions that ensure reliability, regulatory adherence, and superior performance. As an ISO 13485:2016 Certified Testing Partner, we bring deep domain expertise, agile methodologies, and industry best practices to accelerate your product innovation while minimizing risks. Our specialized Medical Device Testing CoE enables seamless Verification & Validation of next-gen healthcare solutions — from life-saving implants to AI-powered smart devices — ensuring trust, qality, and patient safety at every touchpoint.

AMZ’s Medical Devices Testing Center of Excellence (CoE) delivers unparalleled expertise and value-driven testing solutions tailored for the Healthcare & Life Sciences sector. Our specialized testing frameworks are designed to accelerate compliance, enhance product reliability, and ensure patient safety across Class I, II, and III Medical Devices. Leveraging risk-based testing methodologies like FMECA, we strategically align test coverage to uncover critical defects early. Our in-depth capabilities span Quality Control Checks, System Suitability Tests, Analytical Instrument & Method Validations — ensuring your devices meet the highest standards of precision, performance, and regulatory expectations. With certified domain experts and continuous in-house training programs, we empower your innovation journey with quality-driven digital assurance.

AMZ’s Medical Device Testing Center of Excellence

AMZ’s strategic Analysis Phase focuses on aligning testing processes with regulatory standards and business goals, ensuring a seamless validation journey for medical devices.

  • Identify Medical Devices within project scope and assess regulatory compliance requirements

  • Define and finalize a tailored Testing Methodology, Approach, and Key Deliverables

  • Develop a Risk-based Validation Plan to ensure product safety, functionality, and reliability

  • Gather and Document Business, Functional, and Regulatory Requirements

  • Perform Design Qualification for systems, equipment, and medical devices

  • Conduct a comprehensive Risk Assessment to identify potential failures and critical areas

  • Perform an Impact Assessment for all change-driven processes and components

  • Create a detailed Validation Master Plan (VMP) aligning with industry regulations

  • Develop an Effective Communication & Collaboration Model between stakeholders

  • Establish a Metrics Framework to track quality, compliance, and performance

Medical Device Testing Approach

Regulatory standards and compliance guidelines, especially those mandated by the Food and Drug Administration (US FDA), play a critical role in ensuring the safety, accuracy, and quality of Medical Device Testing. At AMZ, we specialize in providing end-to-end testing services for highly regulated industries in the United States, driven by stringent state and federal compliance frameworks. Our proven expertise ensures that medical systems and applications meet regulatory expectations while maintaining operational excellence.

We perform a wide range of Verification & Validation (V&V) Testing Services to ensure seamless functionality, user safety, and compliance of Medical Devices and Healthcare Applications:

  • End-to-End Lifecycle Verification & Validation (V&V)

  • Graphical User Interface (GUI) Testing for user-friendly experience

  • High-Performance Testing for speed, stability, and scalability

  • Non-GUI Testing to validate backend processes and system logic

  • Regulatory Compliance Testing adhering to FDA and global standards

  • Interoperability Testing for seamless integration with third-party devices and systems

  • Behavioral Testing to validate expected device responses and operations

  • Reliability Testing to ensure long-term stability and performance

  • User Acceptance Testing (UAT) to ensure product meets customer expectations and business goals

Supported Regulations & Compliances

Computer System Validation (CSV) - Model

AMZ adopts a robust Computer System Validation (CSV) framework designed to deliver comprehensive and regulatory-compliant validation services. Our structured approach ensures accuracy, transparency, and quality at every stage of the system lifecycle, meeting both business objectives and regulatory expectations. With a customer-centric strategy, we help organizations achieve operational excellence through the following offerings:

  • Tailored Validation Strategy integrated with the development lifecycle for better clarity of test objectives

  • Risk-based Validation Methodology for Hardware, Software, and Peripheral Devices ensuring system integrity

  • Verification and Validation of User & Business Requirements aligned with the system’s intended use

  • Implementation of secure authentication protocols ensuring compliance with regulatory standards

  • Efficient and Timely Functional Verification across multiple system modules and environments

  • Detailed Documentation and Comprehensive Reporting to support audits and meet stakeholder expectations

  • Transparent Communication and Collaboration for smooth execution and regulatory approval

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