Software for Medical Devices & Applications
Digitalization has caused a seismic shift in how healthcare is administered and delivered. Software has now become crucial in delivering healthcare solutions across many domains including diagnosis, disease prevention, modernizing care, or treatment of an illness or injury. Software lies at the core of web, mobile, standalone and embedded applications and covers 4 categories:
- Software as a medical device (SaMD), which is standalone software that serves as a medical product in and of itself;
- Software in a medical device (SiMD). This is software that’s part of a medical product, such as implanted software in medical equipment;
- Software as an accessory to a medical device;
- General purpose software that is not a medical product by itself.
SOFTWARE DEVELOPMENT SERVICES
We have a team of experienced and highly skilled solution architects and developers
The solution that we offer comprises software development lifecycle processes and also includes a linear approach like waterfall, an incremental approach like agile, and an integration and delivery approaches like DevOps
Usage of tools such; IBM, Aligned elements, and Atlassian components
Our comprehensive tools can effectively manage, audit, and trace each stage of the software development
MicroGenesis is one of the leading software solution providers for medical software. We offer a single-window for services starting from development, testing, and regulatory compliance to ensure reliable and scalable software. With a comprehensive portfolio of service offerings and a team of skilled experts, MicroGenesis is uniquely positioned to deliver innovative and futuristic solutions to our clients. Our partnership with leading medical device companies has enabled the roll-out of high-quality products in shorter time frames while maintaining regulatory compliance such as; EN ISO 13485, EU MDR, and FDA.
Our extensive experience in offering software solutions has enabled us to develop applications based on the latest technologies, platforms, databases, and languages. By leveraging robust frameworks, we are able to accelerate development, improve quality standards, reduce production and investment costs. Cross platform tools provide a single code base for deployment across various platforms.
Our comprehensive toolset incorporates best practices to effectively manage, audit, and trace each stage of the medical software development :
- Requirements management
- Architecture & design
- UI/UX creation
- Coding to standards
- Version control
- Test/Quality management
Engineering Value to Enhance Quality and Performance
Our comprehensive toolset incorporates best practices to effectively manage, audit, and trace each stage of the medical software development that includes:
TESTING SERVICES
Our comprehensive toolset incorporates best practices to effectively manage, audit, and trace each stage of the medical software development that includes:
Our portfolio features
- Robust asset and framework testing
- Develop testing strategy
- Scope, review, and planning of test process
- Risk analysis
- Defect and configuration management
- Build, operate, and support manage model for end-to-end customer engagement
- Generate reports based on evidence
Our 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 medical software development. The framework minimizes the need for coding and focuses on creating, running, and managing repetitive testing tasks automatically. The solution is ideal to meet the complex demand of modern applications. It is affordable, intuitive, and easy to use and is a single solution for standalone, web, mobile, and API testing.
Test environment automation
MicroGenesis follows the best practices to leverage the test environment automation as the manual infrastructure provisioning for the test automation environment is a time-consuming process. This reduces the overall time taken to carry out test automation.
Test process automation
MicroGenesis implements workflow and business process automation with advanced tools to reduce the time for repetitive tasks. This can improve productivity and accuracy while improving the business insight to make informed decisions.
Regulatory compliance services
The regulatory requirements specified in ISO 13485 and EU MDR focus on the compliance of the development process so that risk-free and compliant software can be released to the market. We meet the IEC 62304 regulatory standard for software development lifecycle requirements.
Companies dealing with medical software must implement a Quality Management System (QMS) to ensure compliant medical device software development. MicroGenesis has many years of experience in implementing QMS for medical software. Our pre-configured Medical Software Engineering, Medical Audit, and CAPA Templates can save configuration time and compliance effort for our clients.
Our consulting and implementation services feature the following:
- Assess the requirement for a quality management system
- Calibrate the quality management system with the existing quality team
- Optimize the tools and applications
- Deploy a compatible quality management system
- 24×7 support and remote management of the quality management system