Medical Device 测试 服务

正规网赌十大排行的 QA experts at ImpactQA specializes in verification 和 validation of medical devices used by Doctors, 外科医生, Ophthalmologists, Endocrinologists, & Cardiologists to deliver a safe 和 secure experience to all the patients

10x Faster Release Capacity with ImpactQA’s
Medical Device 测试 服务

正规网赌十大排行的 dedicated medical device testing experts help verify & validate software for cardiac pacemakers, surgical instruments, ultrasound scanners, orthopaedic implants, haemodialysis machines 和 contact lenses. 正规网赌十大排行的 team is fully capable of helping Fortune 500 clients test their cloud, AI or 物联网 based medical & healthcare devices such as health tracking smart watches, digitalized beds, sterilization equipment for pets 和 more.

网络 & 移动测试

网络 & 移动
测试

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

临床 验证

临床
验证

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

协议 测试

协议
测试

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

安全 测试

安全
测试

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

GUI测试

GUI
测试

With GUI testing, UI issues like user confusion, usage delay 和 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

  • 整形外科
  • 耳科
  • 脊柱
  • 创伤
  • ENT
  • 物联网网关
  • Remote Monitoring Systems
  • Embedded electronics & Single Use Devices

Gartner的标志

Critical Capabilities for Quality Assurance 服务 Worldwide

“We utilize ImpactQA services for our mobile application testing needs in order to help us improve app quality 和 scale the business. We lacked in-house expertise in mobile testing domain for Android 和 iOS 和 needed quick solutions for automating our app testing suite. Team is well equipped with the latest QA technologies 和 their engineers helped us in devising a test strategy. Their support was amazing during the implementation.”

正规网赌十大排行的 Testimonials

Offering for the Life Sciences Industry

Medical Device 测试 服务 at ImpactQA

功能 <br>测试

功能
测试

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

Conformance 和 Compliance 测试

Conformance 和 Compliance 测试

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

Review Design Specifications 和 Gap Analysis

Review Design Specifications 和 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 和 more

物联网 <br>测试

物联网
测试

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

Performance (Load 和 Stress) 测试

Performance (Load 和 Stress) 测试

正规网赌十大排行的 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 和 is erased after it’s been sent successfully

Enterprise Workflow 测试

Enterprise Workflow 测试

From devising QA 和 testing strategy for mechanical design to performing regulatory services, electronic design 和 development, 失效模式 & effects analysis (FMEA), the enterprise workflow testing we provide is highly scalable, 可靠的, robust 和 user-friendly

System Integration & Interface 测试

System Integration & Interface 测试

System integration testing occurs after each one of the modules are integrated 和 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 dem和 for interoperability testing 和 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 测试

测试 Experts for Medical Device Software

测试 Experts for Medical Device Software

正规网赌十大排行的 medical device testing experts are proficient at working within regulated environments such as US FDA, 欧盟(质量体系, CER, 21 CFR Part 820 Quality Management Systems along with ISO14971 和 IEC62304) FDA, 我:E2B, PMDA, Health Level 7 (HL7), GAMP 和 21 CFR part 11, HIPAA Compliance, DICOM St和ards 和 more.

医疗保健 & Life Sciences Software 测试

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

医疗保健 & Life Sciences Software 测试

Test System Engineering for Medical Devices

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

Test System Engineering for Medical Devices

Medical Device 测试 Service Differentiators

15+ Years of Domain Expertise

We have experts with 15+ years’ experience in medical devices with capabilities in 整形外科, Cardiovascular, IVD 和 hospital disposables.

Medical Device Verification & 验证

正规网赌十大排行的 dedicated QA team has capabilities in Mechanical, 电, Quality 和 Regulatory of medical devices in major markets including USA & 欧洲.

Hospital 临床 System 测试

正规网赌十大排行的 skills also include developing Design Dossiers (DHF/Tech Files), 510 (K) applications, UDI implementation, Remediation of the Class I, II 和 III products, 和 CAPA Management.

正规网赌十大排行的 Medical Regulatory Compliance

ImpactQA has expertise on IEC 60601 3rd edition in the areas of spine, ENT, 创伤, 眼科, 物联网网关, embedded electronics, remote monitoring systems, emergency care 和 single use devices.

Quality Assurance for EHR & 电子病历系统

正规网赌十大排行的 testing specialists need to test (EHR Electronic Health Record) 和 EMR (Electronic Medical Record) systems to electronically segment patient’s health information in a digital format.

正规网赌十大排行的 Key 客户

Strategy 和 Planing

Consult our QA Experts for Medical Device 测试 服务

improve testing

博客

How to improve mobile app testing process?

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案例研究

案例研究

Improved the User Experience for the World's Second Largest Food Chain Company. Increased App Retention 和 User Engagement by 50%

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奖

奖 & 认识

See our accomplishments as a global leader in software testing industry.

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