ELAARSON Medical Device Testing Service | Complete QA

Medical Device Testing Services for Intelligent Tech Solutions

Verification & Validation of surgical instruments, contact lenses & ultrasound scanners, orthopaedic implants & haemodialysis machines, cardiac pacemakers & Medical Devices for Diagnostics, Dental, Orthopaedics, Surgical, Cardiology, & Imaging

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 help you address challenges in Medical device software testing and also in implementing guidelines & best practices in software testing lifecycle of these devices. ELAARSON’s dedicated Medical Devices Testing CoE experts help Verify & Validate Software for surgical instruments, contact lenses & ultrasound scanners, orthopaedic implants & haemodialysis machines, cardiac pacemakers. Our experts are fully capable of helping Clients test their smart, AI-based medical & healthcare devices such as Intelligent Beds, sterilization equipment, tool kits for Pets, etc.

Testing Services help increase release capacity of Medical devices manufacturer

Adopting DevOps in the healthcare industry is necessary to align the technological developments with the rapid medical advancements at speed.

A leading Medical Devices & Consumer goods manufacturer wanted to enable a CI/CD pipeline through effective DevOps implementation.
Know how ELAARSON increased their release capacity by 30% and reduced deployment efforts & costs up to 85%.

Medical Device Testing Approach

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
● Metrics framework

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 Test Execution 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

Testing Services help increase release capacity of Medical devices manufacturer

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

ELAARSON’s Medical Device Testing Center of Excellence

✔ ELAARSON’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
✔ 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