Medical Device Testing Services

Our QA experts at ImpactQA specializes in verification and validation of medical devices used by Doctors, Surgeons, Ophthalmologists, Endocrinologists, & Cardiologists to deliver a safe and secure experience to all the patients

10x Faster Release Capacity with ImpactQA’s
Medical Device Testing Services

Our dedicated medical device testing experts help verify & validate software for cardiac pacemakers, surgical instruments, ultrasound scanners, orthopaedic implants, haemodialysis machines and contact lenses. Our team is fully capable of helping Fortune 500 clients test their cloud, AI or IoT based medical & healthcare devices such as health tracking smart watches, digitalized beds, sterilization equipment for pets and more.

Web & MobileTesting

Web & Mobile

We provide end-to-end automation testing, performance testing, functionality testing and compatibility testing of the medical web applications

Clinical Validation


We deliver advisory and digital quality assurance services with a strong emphasis on quality, scalability, reliability and more

Protocol Testing


When it comes to medical device testing, custom protocols can be created in order to develop and meet specialized testing needs and requirements

Security Testing


Team of security testing experts are responsible for covering vulnerabilities issues and potential breaches associated with protected health information (PHI)

GUI Testing


With GUI testing, UI issues like user confusion, usage delay and wrong data entry input errors can be prevented so that they do not become a life-threatening situation during real-life application.

medical test cycle

Excellence in Key Domains

  • Orthopaedics
  • Otology
  • Spine
  • Trauma
  • ENT
  • IOT Gateways
  • Remote Monitoring Systems
  • Embedded electronics & Single Use Devices

Offering for the Life Sciences Industry

Medical Device Testing Services at ImpactQA

Functional <br>Testing


The functional testing of a medical device consists of testing different test scenarios on functional blocks such as instruments, operating system, hardware etc., which must be validated and verified for their operational effectiveness

Conformance and Compliance Testing

Conformance and Compliance Testing

By performing the conformance and compliance testing for a medical device, it is ensured that the federal and regulatory criteria set for quality and safety is following the optimal quality of design and manufacturing practices

Review Design Specifications and Gap Analysis

Review Design Specifications and Gap Analysis

Medical device testing review gap analysis of documents, such as technical files/design dossiers, usability engineering reports, risk documents, Design Controls (DHF), validation documents, clinical evaluation reports and more

IoT <br>Testing


We bring your innovative IoT medical device to market faster with our software testing solutions – from EMI/EMC pre-compliance testing, to wireless device characterization, our cloud based IoT labs help you enable real-time monitoring of your devices

Performance (Load and Stress) Testing

Performance (Load and Stress) Testing

Our performance & load testers ensure that data transmission is unaffected by external disruptions in the user’s internet connection. All Protected Health Information (PHI) data is backed up before transferring and is erased after it’s been sent successfully

Enterprise Workflow Testing

Enterprise Workflow Testing

From devising QA and testing strategy for mechanical design to performing regulatory services, electronic design and development, failure modes & effects analysis (FMEA), the enterprise workflow testing we provide is highly scalable, reliable, robust and user-friendly

System Integration & Interface Testing

System Integration & Interface Testing

System integration testing occurs after each one of the modules are integrated and tested successfully during the software testing lifecycle. Hence, the software is merged with the hardware to ensure that both will work together as a system

Interoperability of Medical Devices

Interoperability of Medical Devices

The healthcare sector faces a huge demand for interoperability testing and hence Test automation is implemented to create a strong QA environment to ensure that every aspect of the software/application is tested to assure interoperability

Expertise in Medical Device Testing

Testing Experts for Medical Device Software

Testing Experts for Medical Device Software

Our medical device testing experts are proficient at working within regulated environments such as US FDA, EU (ISO13485, CER, 21 CFR Part 820 Quality Management Systems along with ISO14971 and IEC62304) FDA, ICH: E2B, PMDA, Health Level 7 (HL7), GAMP and 21 CFR part 11, HIPAA Compliance, DICOM Standards and more.

Healthcare & Life Sciences Software Testing

We can help you adopt digital transformation while keeping the reduced cost and making sure the system performs consistently to produce its pre-determined specifications and quality attributes. Offering for the life science industry business solutions QSR, technology differentiators FDA, niche services CRM and more.

Healthcare & Life Sciences Software Testing

Test System Engineering for Medical Devices

To ensure reliability and readability of medical devices, QA engineering team executes a greater number of testing services such as regression testing, stress testing, safety testing, black box testing, white box testing, hardware testing, robustness testing, and more. So, rely on ImpactQA’s medical device testing experts who derive a cross functional expertise in providing the safe and secure medical devices.

Test System Engineering for Medical Devices

Strategy and Planing

Consult Our QA Experts For Medical Device Testing Services

Medical Device Testing Service Differentiators

15+ Years of Domain Expertise

We have experts with 15+ years’ experience in medical devices with capabilities in Orthopaedics, Cardiovascular, IVD and hospital disposables.

Medical Device Verification & Validation

Our dedicated QA team has capabilities in Mechanical, Electrical, Quality and Regulatory of medical devices in major markets including USA & Europe.

Hospital Clinical System Testing

Our skills also include developing Design Dossiers (DHF/Tech Files), 510 (K) applications, UDI implementation, Remediation of the Class I, II and III products, and CAPA Management.

Our Medical Regulatory Compliance

ImpactQA has expertise on IEC 60601 3rd edition in the areas of spine, ENT, trauma, ophthalmic, IOT Gateways, embedded electronics, remote monitoring systems, emergency care and single use devices.

Quality Assurance for EHR & EMR Systems

Our testing specialists need to test (EHR Electronic Health Record) and EMR (Electronic Medical Record) systems to electronically segment patient’s health information in a digital format.

Our Key Clients


Subscribe to our newsletter

Get the latest industry news, case studies, blogs and updates directly to your inbox

1+1 =