Software For Medical Devices & Applications
Integrating next-gen technology with compliance for improved healthcare
Software has become a critical component for the delivery of healthcare in this decade. Software resides in mobile apps, web apps, standalone systems and in highly sophisticated medical devices.
MicroGenesis is a leading software solutions provider for medical devices and applications. We provide a single window of services in Development, Testing and Regulatory Compliance for medical software including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).
Our team with its wealth of experience and scale have built a comprehensive portfolio of service offerings to deliver innovative and futuristic solutions to our clients. Our partnership with leading medical device companies have enabled them to bring quality products to the market in shorter time frames and meet EN ISO 13485, EU MDR and FDA Regulatory compliance.
Software Development Services
Our software development services are centred around:
A team of expert solution architects and developers
Software Development Lifecycle processes that include waterfall, agile and DevOps
Tooling that includes IBM, Aligned Elements and Atlassian components
We are well-positioned to develop applications built using innovative technologies, platforms, databases, and languages. By leveraging robust frameworks, the software is pieced together by our team that is focused on accelerating development, reducing costs, enhancing quality levels, faster time to market and certainty in delivery.
We are well-positioned to develop applications built using innovative technologies, platforms, databases, and languages. By leveraging robust frameworks, the software is pieced together by our team that is focused on accelerating development, reducing costs, enhancing quality levels, faster time to market and certainty in delivery.
Our development techniques include the use of frameworks for building loosely coupled, maintainable, and testable applications. These frameworks provide an implementation of a collection of design patterns that are helpful in writing well-structured and maintainable applications, including MVVM and others.
We use latest technologies to build cross-platform native mobile apps for Android, iOS, Mac, and Windows devices. This not only allows you to share code across the Android, iOS, Windows, and MacOS platforms, you can also share code between your mobile, web, and desktop apps.
We provide best practices and comprehensive tooling to manage and provide auditability and traceability for all aspects of software development including:
⦁ Requirements management
⦁ Architecture & design
⦁ UI/UX creation
⦁ Coding to standards
⦁ Version control
⦁ Test/Quality management
Our partnerships with leading Vendors such as IBM, Atlassian and Aligned elements enable us to provision state-of-the- art tooling for the DEVELOPMENT LIFECYCLE and medical compliance management.
Testing Services
Automation of the testing process will speed up project schedules and report on metrics for informed release decisions. MicroGenesis implements Workflow and Business process automation with state-of-the-art tooling to reduce the amount of time needed to complete a task. This can result in higher productivity rates for routine tasks. The automated system provides a visual and organized platform where all stakeholders have a centralized view of the process status.
Our Portfolio Features
Robust testing assets & frameworks
Testing strategy development
Test process scoping, review & planning
Risk analysis
Defect management and Configuration management
Build-Operate-Support-Manage model for end to end customer engagement
Evidence backed reports based on ISO 13485 & 62304 guidelines
MicroGenesis test Automation rests on 3 pillars:
Test Automation Framework
Our unique, proprietary, configuration-based test automation framework is designed to meet the growing demand for continuous testing of medical software. The framework minimizes the need for coding and focuses on creating, running and managing testing tasks. The solution is ideal to meet the complexity of modern applications and is affordable, intuitive and easy to use. It is one solution for standalone, web, mobile and API testing. It is also device, browser and platform agnostic.
Test Environment Automation
Manual infrastructure provisioning for the test automation environment is a time-consuming process. MicroGenesis adopts best practices and leverages automation to drastically reduce the cycle time to set up test environments. This, in turn, reduces the time to release without affecting compliance and standards.
Test Process Automation
Automation of the testing process will speed up project schedules and report on metrics for informed release decisions. MicroGenesis implements Workflow and Business process automation with state-of-the-art tooling to reduce the amount of time needed to complete a task. This can result in higher productivity rates for routine tasks. The automated system provides a visual and organized platform where all stakeholders have a centralized view.
Regulatory Compliance Services
The paramount concern in medical device software development is Safety. Safe medical device software requires risk management, quality management and good software engineering. Regulatory requirements specified in ISO 13485 and EU MDR focus on development process compliance and enable the release of safe software to the market.
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software.
The standard requires all aspects of the software development life cycle to be scrutinized. Medical device companies need to implement a Quality Management System which captures all aspects of the process for compliance in the development of the software. MicroGenesis has over 2 decades of experience in implementing Application Lifecycle Management (ALM) for medical devices to meet the requirements of medical device regulations. MicroGenesis has expertise in leading vendor tools to provide the most optimum solution to meet your needs.
We provide consulting and implementation services for:
⦁ Assessing your QMS requirements
⦁ Enabling your QA team to effectively use the QMS
⦁ Identifying the optimum tool set
⦁ Implementing your QMS
⦁ Remote managed 24×7 support of the QMS
Support Regulatory Compliance management and Auditing tools implementation
Automate mature design control for medical software development, quality process & audit management, and comprehensive risk management through regulatory and compliance tools. Deliver better quality outcomes, and make medical device product quality a source of competitive advantage.
Leverage ready-to-use process library for quality, development, risk management, and approval processes in the delivery of digital medical devices. Implement a comprehensive quality management system, improve quality performance, and design clinically effective medtech solutions that improve patient experience.
Our services will enable you to shorten design and development cycles, reduce quality costs, and accelerate regulatory certification. Our pre-configured Medical Software Engineering Template and Medical Audit and CAPA Templates will save configuration time and compliance effort.
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