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 & Mobile
We deliver advisory and digital quality assurance services with a strong emphasis on quality, scalability, reliability and more
When it comes to medical device testing, custom protocols can be created in order to develop and meet specialized testing needs and requirements
Team of security testing experts are responsible for covering vulnerabilities issues and potential breaches associated with protected health information (PHI)
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.
Excellence in Key Domains
- IOT Gateways
- Remote Monitoring Systems
- Embedded electronics & Single Use Devices
Medical Device Testing Services at ImpactQA
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
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
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
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
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
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 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
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
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.
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.
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.