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