TESTING SOLUTIONS FOR MEDICAL DEVICE
SOFTWARE VALIDATION VERIFICATION
Leverage Cigniti’s Medical Device testing CoE for quick upscaling of
QA teams; Reap benefits of Cigniti’s Medical device testing expertise.
MEDICAL DEVICES TESTING SERVICES
Medical devices are very critical as they have a direct impact on the lives of patients. To deliver superior and safe experiences to patients, medical device manufacturers are continuously innovating the devices with the help of software. However, with the benefits of software come the risk of defects and bugs.
At Cigniti, we help transform an innovative design into a reliable and successful product with our independent verification & validation (V&V) practices for Medical devices. Our V&V services include an end-to-end test life cycle offering involving process, people and tools. We provide test design, execution, and documentation by employing a proven quality program that helps our clients achieve multiple business benefits.
CIGNITI’S MEDICAL DEVICES TESTING SERVICES OVERVIEW
Medical device testing demands rich experience of the domain, local and federal legislations, knowledge of devices, infrastructure and capability to support the testing. At Cigniti, we understand this and thus have been the chosen Software Testing services partner for large Medical Device manufacturers and users. We help you address challenges in Medical device testing and help you implement guidelines & best practices in software testing lifecycle of these devices.
Few Highlights of Cigniti’s Medical Device Testing Center of Excellence (MDTCoE) are:
- Expertise in Verification & Validation of Class I, Class II and Class III 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 domain training & certification for healthcare and Life Sciences Domain
MEDICAL DEVICES TESTING APPROACH
Cigniti follows a 5-step testing approach which is aligned with the development lifecycle enabling a better understanding of the test requirements. Our Risk-based approach to validate the hardware, software and Peripheral Devices Testing allows us to test user & business requirements associated with the intended use of the system.
REGULATIONS AND COMPLIANCES – A CRITICAL COMPONENT
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
YOU MUST KEEP ABREAST OF THE LATEST MEDICAL TECHNOLOGIES AND MEDICAL MARKET DEMANDS
“If not properly secured, medical devices, such as bedside telemetry or implantable devices like pacemakers and insulin pumps, can introduce malware to the network or, in extreme cases, be hacked, and could harm the individual whose medical device was compromised,”- Lynne A. Dunbrack, Research Vice President, IDC Health Insights
- Healthcare sector needs a robust Cybersecurity planWith a view to address issues related to safety of Medical devices, the Food and Drug Administration (FDA) has announced plans to propose new frameworks to protect consumers and enhance medical device cybersecurity. It has released the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health that outlines how the agency can work towards […] The post Healthcare sector needs a robust Cybersecurity plan appeared first on Software Testing Blog by Cigniti Technologies. Read more »
- Top 6 Reasons Why the Healthcare Sector Needs QA & TestingSpeed and quality are the core essentials for serving the healthcare sector effectively. The challenges and undying demands of the sector have led to major inventions and enhancements. Digitization is one of the major breakthroughs that healthcare has witnessed. It implies connecting people and devices, and deriving meaningful inferences from the data generated to offer […] The post Top 6 Reasons Why the Healthcare Sector Needs QA & Testing appeared first on Software Testing Blog by Cigniti Technologies. Read more »
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“If not properly secured, medical devices, such as bedside telemetry or implantable devices like pacemakers and insulin pumps, can introduce malware to the network or, in extreme cases, be hacked, and could harm the individual whose medical device was compromised.”
—Lynne A. Dunbrack, Research Vice President, IDC Health Insights