Optimize medical device testing outcomes with our Digital Assurance Services solutions.
IoT Assurance improves automation coverage by 50%
Increase release capacity by 30%, reduce deployment costs by 85%
Our Key Clients
Here are few of the leading organizations who rely on Cigniti’s Medical Device Testing experts:
Channeling the Power of Automation in Medical Device Testing
10 Testing Recommendations for Software as Medical Device
Medical Devices Testing services
Medical devices form a critical part of the Healthcare & Life Sciences industry as they have a direct impact on the lives of patients. To deliver a superior and safe experience to patients, medical device manufacturers need to continuously innovate the devices with the help of software. However, with the benefits of software come the risk of defects and bugs. Medical device testing thus demands rich experience of the domain, local and federal legislations, knowledge of devices, infrastructure and capability to support the testing.
We are an ISO13485:2016 Certified Organization & the chosen Software Testing services partners for large Medical Device manufacturers and users. We help you address challenges in Medical device software testing and also in implementing guidelines & best practices in software testing lifecycle of these devices.
Cigniti’s dedicated Medical Devices Testing CoE experts help Verify & Validate Software for surgical instruments, contact lenses & ultrasound scanners, orthopaedic implants & haemodialysis machines, cardiac pacemakers.
Medical Device Testing Approach
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
Computer System Validation (CSV) - Model
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