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MEDICAL DEVICES TESTING SERVICES

Restorative gadgets are extremely basic as they directly affect the lives of patients. To convey better and safe encounters than patients, restorative gadget makers are persistently improving the gadgets with the assistance of programming. Be that as it may, with the advantages of programming come the danger of deformities and bugs.

At TGGTECH, we help change a creative outline into a solid and fruitful item with our free check and approval (V&V) hones for Medical gadgets. Our V&V administrations incorporate a conclusion to-end test life cycle offering including procedure, individuals and instruments. We give test plan, execution, and documentation by utilizing a demonstrated quality program that enables our customers to accomplish various business benefits.

TEST AUTOMATION METHODOLOGY

Restorative gadget testing requests rich experience of the space, nearby and government enactments, learning of gadgets, framework and capacity to bolster the testing. At TGGTECH, we comprehend this and accordingly have been the picked Software Testing administrations accomplice for huge Medical Device makers and clients. We enable you to address challenges in Medical gadget testing and enable you to execute rules and best practices in programming testing lifecycle of these gadgets.



Few Highlights of TGGTECH’s Medical Device Testing Center of Excellence (MDTCoE) are:

  • 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 domain training & certification for healthcare and Life Sciences Domain

MEDICAL DEVICES TESTING APPROACH

TGGTECH takes after a 5-stage testing approach which is lined up with the improvement lifecycle empowering a superior comprehension of the test necessities. Our Risk-based way to deal with approve the equipment, programming and Peripheral Devices Testing enables us to test client and business prerequisites related with the expected utilization of the framework.

Analysis Phase

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

Design Phase

  • Final Validation Plan
  • Protocol Development
  • Author test cases/scripts
  • Build validation approach
  • Requirement traceability matrix
  • SOP Development
  • Collaborate with Client on test data requirements
  • Validation training
  • Sign off from cilent

Deployment Phase

  • Smoke testing on the test environment
  • code/document reviews
  • perform test execution
  • Execution of verification and validation documentation suite
  • Defect logging and retesting
  • Execution summary report
  • Sign off from client

Closure Phase

  • Hardware and Software test execution report
  • Defect summary report
  • Metrics and SLA's
  • 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

What Clients Says

Just Perfect!

Jane Doe

TGG Tech was willing and able to listen to our needs and provide us with an excellent solution. Thanks guys..

- Paul Anderson

Thanks!

Jane Doe

I’ve been quite satisfied with the projects that I’ve worked with them and yes, I’d be willing to work with them on future projects that we do.

- John Doe

Great!

Jane Doe

We been working with TGGTECH and they’ve been able to adapt those processes to fit our team as well as the Freeman culture.

- Louis

Contact Us

Consult our experienced team of career testers for your Testing requirements.

REGULATIONS AND COMPLIANCES – A CRITICAL COMPONENT

Directions and Compliances especially from the Food and Drug Administration (US FDA) assumes an essential part with regards to Medical gadgets testing. We have ability in testing profoundly controlled mechanical areas in United States, represented and coordinated by different state administrative bodies and government administrative specialist.

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

THOUGHT LEADERSHIP

TGGTECH is a thought leader in the test data management domain and publishes regular Blogs and WhitePapers to share the latest trends and best practices.

Incredible Approaches for Test Data Generation that Will Make You Worry-Free!

Test Data Management Challenges in Healthcare Industry

Test Data Management is Critical for Business Success