Medical Device Testing Services

Cigniti follows a 5-step testing approach which is aligned with the development lifecycle enabling a better understanding of the test requirements. Our Risk-based approach to validate the hardware, software and Peripheral Devices Testing allows us to test user & business requirements associated with the intended use of the system.

Analysis Phase

• Determine Medical devices in scope and regulatory compliance needs
• Finalize Test Methodology, Approach and Deliverables
• Validation Plan
• Document requirements
• Design qualification
• Risk assessment
• Impact assessment
• Validation Master Plan
• Communication Model
• Metrics framework

Design Phase

• Finalize Validation Plan
• Protocol development (IQ, OQ, PQ)
• Author Test cases/Scripts
• Build Validation Approach
• Requirement Traceability matrix
• SOP development
• Colaborate with Client on test data equirements
• Validation Training
• Sign off from client

Deployment Phase

• Smoke testing on the test environment
• Code / document reviews
• Perform test execution
• Execution of Verification and Validation documentation suit (for IQ, OQ, PQ)
• Defect Logging and Retesting
• Execution summary report
• Sign off from Client

Closure Phase

• Hardware and software Testexecution Summary Report
• Defect Summary Report
• Metrics and SLAs
• System Release GO/No-Go Dashboard
• Best Practices and Lesson Learnt

Maintenance Phase

• Change control plan
• Change request
• Risk assessment
• Impact assessment
• Approval of change
• Implementation of change
• Re-validation of system as per requirements
• System release Go/No-Go dashboard

Regulations and Compliances particularly from the Food and Drug Administration (US FDA) plays an important role when it comes to Medical devices testing. We have expertise in testing highly regulated industrial sectors in United States, governed and directed by various state regulatory bodies & federal regulatory authority.

We conduct following types of testing to Verify and Validate Medical Systems and its Applications:

• Lifecycle V&V
• GUI Testing
• Performance Testing
• Non-GUI Testing
• Compliance Testing

• Interoperability Testing
• Behaviour Testing
• Reliability Testing
• User Acceptance Testing

Cigniti’s Medical Devices Testing Center of Excellence provides the following unique values to multiple organizations:

• Expertise in Verification & Validation of Class I, Class II and Class III Medical Devices in the area of Diagnostics, Imaging, Orthopaedics, Surgical, Cardiology, and Dental
• Testing strategy to satisfy the demands of both the public and the regulatory bodies
• Expertise in Verification & Validation of various Medical Devices
• Testing approach that matches test coverage to parameters that will reveal the defects most likely to occur
• Risk Based Testing using Design Failure Modes, Effects and Criticality Analysis (FMECA)
• In-house training & certification for Healthcare and Life Sciences Domain

It also provides the following expertise in Medical Device Testing:

• Quality Control Checks – Verifies Accuracy of Sample Analysis
• System Suitability Tests – Verifies System Performs according to Analysts Expectations
• Analytical Instrument Validation – Proof Suitability of the instrument for the intended use
• Analytical Method Validation – Proof that analytical procedure does what it purports to do

Cigniti practices a CSV model that helps provide the following services:

• Validation approach aligned with development enabling better understanding of the test requirements
• Risk based approach to validate the Hardware, Software and Peripheral Devices
• Testing of the User & Business requirements associated with the intended use of the system
• Equipped with the mandatory authentication checks for the regulatory compliances
• Functional and Timely verification across various components
• Through reporting for external and internal stakeholders