With Gadgeon's V&V services, clients benefit from
accelerated development cycles, minimized risks, and
a higher quality end product that meets both regulatory
and customer expectations.
Gadgeon ensures that your device meets the necessary requirements for regulatory bodies such as the FDA, ISO 13485, CE marking, and other international standards.
Verifying adherence to the FDA's 21 CFR Part 820 Quality System Regulations and design control requirements.
Ensuring compliance with the IEC 60601 standard for the safety and effectiveness of medical electrical equipment.
Testing devices for risk management and hazard identification according to ISO 14971.
Gadgeon provides expert IEC 62304 consulting services to help medical device manufacturers achieve compliance with the international standard for software lifecycle processes.
Guidance on implementing structured software development and maintenance processes.
Identifying, assessing, and mitigating software-related risks as per IEC 62304 guidelines.
Creating and reviewing required documents, including Software Development Plans, Hazard Analysis, and Verification & Validation reports.
Ensuring readiness for regulatory audits and certifications.
Our comprehensive testing approach validates all aspects of device design, ensuring adherence to regulatory and performance standards.
Verifying that the device performs all functions as defined in the design specifications.
Ensuring that the device meets the performance criteria under normal and extreme operating conditions.
Testing devices for resilience under various environmental conditions, such as temperature, humidity, and vibration.
Verifying the software embedded in medical devices to ensure reliable operation and functionality.
Gadgeon offers comprehensive Design Validation Services to ensure the device meet user needs, intended use, and regulatory requirements.
Testing devices under real-world conditions to confirm they meet end-user expectations.
Ensuring the device aligns with regulatory standards like FDA, ISO 13485, and IEC 60601.
Evaluating the usability & safety to minimize risks in an actual Industry setting (like clinical settings for a Medical device).
Performing tests in simulated environments to validate device performance and reliability.
Embedded devices has complex software systems that need to be rigorously tested to ensure safe and reliable operation. Gadgeon offers specialized software verification and validation services for Medical Devices to meet FDA and IEC standards.
Verifying that the software performs its intended functions without errors.
Testing individual software units and their integration within the device.
Testing software functions that are critical to patient safety to ensure reliability.
Ensuring compliance with IEC 62304, the international standard for software lifecycle processes for medical device software.
Gadgeon provides specialized cybersecurity testing services to ensure that the device meet the stringent requirements of FDA and other industry standards.
dentifying and mitigating security vulnerabilities to safeguard sensitive patient data and ensure device integrity. Assessing potential cyber threats and evaluating their impact on device performance and safety.
Aligning cybersecurity measures with FDA guidelines for medical device software. Validation of embedded systems against cybersecurity guidelines from the FDA and other regulatory bodies perspective.
Simulating attacks to evaluate system weaknesses and reinforce device security. Performing penetration testing, threat modeling, and vulnerability assessments to ensure security compliance, including encryption, secure boot, and data protection.
Testing for compliance with FDA's pre-market cybersecurity guidance, ensuring that the medical device is secure throughout its lifecycle.
Gadgeon offers Performance and Reliability Verification services to ensure that the devices are consistently operating as intended under real-world conditions.
Verifying that the device meets its specified functional requirements, including accuracy, response times, and user interaction.
Evaluating the device's ability to perform reliably under extended use, environmental stress, and extreme conditions.
Assessing device performance under various environmental factors such as temperature, humidity, and electromagnetic interference (EMI).
Ensuring the device meets regulatory requirements, including ISO 13485 and IEC 60601 for safety and performance.
Gadgeon offers Automated Testing to enhance the efficiency, accuracy, and repeatability of testing of embedded devices. These services will help ensuring compliance with regulatory standards while reducing time-to-market.
Developing custom automated testing frameworks tailored to specific device requirements.
Automating repetitive tests to verify device functionality, performance, and user interface under various conditions.
Ensuring new software updates do not negatively impact existing device functionality or safety.
Generating comprehensive test reports for regulatory submissions, ensuring adherence to standards such as ISO 13485 and FDA guidelines.
As part of our comprehensive Verification and Validation Services, Gadgeon ensures traceability and documentation to enable product compliance, quality, lifecycle management, and regulatory certification.
We will ensure complete traceability of testing and validation efforts to ensure all requirements, from design to testing, are documented and verifiable.
Creation of validation protocols, test reports, and compliance documentation that meet FDA, ISO, and other regulatory submission standards.
Support for submission processes to FDA, CE marking, and other certification authorities by providing detailed V&V reports and documentation.
Our meticulous approach ensures transparency, accelerates certification processes, and enhances confidence in product reliability and compliance.
Partner with Gadgeon for dependable device Verification & Validation
that ensures safety, compliance, and reliability!
Commonly used for automation scripts in testing devices and hardware interfaces.
Frequently used in embedded systems for low-level device verification, especially for firmware validation.
Used in automated testing frameworks, particularly for web-based and IoT device interfaces.
Essential for hardware description and verification in FPGA and ASIC designs.
LabView, NI TestStand
Cadence Xcelium, Mentor graphics ModelSim.
Tessy, Klocwork.
Jenkins, GitLab CI/CD
An open-source IDE used for embedded development.
Define verification and validation strategies early in the design phase for comprehensive test coverage.
Prioritize testing based on risk assessment, focusing on critical functionalities that have the highest potential impact.
Automate repetitive tests, especially for regression testing.
Use simulation tools for early testing of device designs before physical prototypes are available.
Ensure testing processes align with relevant industry standards (e.g., ISO 13485 for medical devices).
Maintain a traceable link between requirements, design, and testing.
Regularly review and refine test processes.
With a focus on quality, patient safety, and regulatory compliance, we help you bring innovative
medical devices to market with confidence.
