Medical Device Software Lifecycle Management System
Seamlessly Integrated Solution Including
Quality, Risk, Software Development, Document Management System With
Automated Graphical Business Process Management
Drag and Drop No-code Configuration for Unlimited Expansion
Single Click Generation of Fully Formatted Word Report
Largest Integrated Ecosystem of Development Tools
In contrast to traditional medical devices that are typically untouched by the device OEM once the product start shipping, medical device software manufacturers make continuous, post-release changes to medical device software products remotely. For example, medical device software manufacturer may release a security patch or a new product feature. How do they handle releasing a newer product version while complying with FDA approval guidance?
Many medical device software use Machine Learning and Deep Learning techniques. AI-based medical device software products can improve device efficacy by continuously adding patient data. How do you meet the security compliance for sharing real-world data (RWD) to a centralized (Cloud-based) inference engine? How doe medical device software developers update the algorithm’s functionality as the AI algorithms “learn” better, without going through re-approval by the FDA?
OEMs of a traditional medical device do not depend on third party technology elements for developing a product. In contrast, medical device software developers will be using a plethora of third party elements like Public Cloud, Internet connectivity (including local and wide-area network), IOT (Internet of Things) data collection at the edge, “Github” like code-repositories, geospatial data, Operating System and functionality of a Smartphone, RWD (Real-World-Data) including clinical and nonclinical patient information, patient-reported health outcomes data, open source code, docker containers, etc. The dependency on third party stakeholders and risks management while navigating through the third-party dependence will challenge the medical device software developers.
MediDev Solutions developed their uniquely differentiated SaaS product for medical device software lifecycle that includes Software development, Quality, Risk, and Document management for this emerging market and addresses the challenges of navigating through the FDA regulations.
The challenge of medical device software Quality Management System (QMS) for document control, verification, validation, and other functions is that it must follow FDA’s guidelines (per ISO 13485) that apply to medical devices.
Defining the approach towards quality management, ISO 13485 states: “This International Standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
One of the unique features of MediDev is its industry strength process engine with a drag and drop visual process designer and tracker. It is the only task-based business process management tool with roles, custom forms, conditional branching, and parallel paths that can model, design, implement, run and enforce any process one can think of.
One critical components of the Quality Management System is the traceability (Section 7.5.9) from any object to another. The objects might be from the Design Control as defined in ISO 13485 – User Needs, design Inputs, Design Outputs, Verification, Validation or the Risks and Hazards from the Risk Management or the users Stories and Testcases from the Agile Development Management.
MediDev allows not just traceability between various objects but multiple traceability relations between the same pair of objects. In addition, MediDev traceability functionality allows impact analysis (i.e. when one item changes all related objects are flagged for potential impacts), orphan analysis (i.e. to decide which objects miss any related objects as per required traceability relations).