TGFR Consulting LLC
Transforming Medical Device Development
The FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices has triggered an increased interest in cybersecurity for medical devices . This guidance from the FDA details the key elements for protecting the medical device. These elements form a hierarchy as Asset – anything that has value to an individual or …
Test design needs to determine the right test level, minimize test overlap and ensure full coverage
Introduction Using agile software development for a medical device is quite possible, providing the process considers and adapts to some key constraints medical development imposes. These constraints include: Development needs defined set of Design Inputs. These input requirements represent an “engineering level of detail” for the system and are derived based upon the intended use, …
System Realization begins following the deployment of the design inputs to the subsystems. The following table describes the inputs and outputs of the realization process The following summarizes the activities involved in system realization Subsystem Development – this involves the development of the subsystem and the associated test methods. Subsystem Integration – the focus here …
Subsystem Requirements deployment takes the outputs of the worksheet development and makes a more detailed allocation of these entries across the subsystems. The deployment allocates requirement values and tolerances across the mapped subsystems. During development of the design worksheet, each of the functional or performance requirements was considered independently. This may lead to a situation …
The Design Worksheet activity creates the detailed mapping from system requirements to the subsystems. During concept development, a preliminary partitioning of the requirements to the subsystems occurred, and that partitioning serves as the basis for this more formal and structured mapping. The process begins with the binning of requirements for subsequent subsystem deployment. The categories …
The development the product begins with the deployment of the design inputs to the subsystems. The following table describes the inputs and outputs of Deployment Process A capability analysis of the manufacturing process and the ability of manufacturing to meet the various performance requirements initiates the process. This analysis drives how the subsystem deployment proceeds …
Subsystem Decomposition Decomposition partitions the system into subsystems. Rarely in today’s world does a system of any complexity not have a subsystem-based architecture. Subsystems satisfy several key needs of modern systems Parallel Development – with lower coupling comes fewer inter-dependencies and thus more parallel effort can be planned. Outsourcing – Subsystem partitioning allow the outsourcing …
The development of the final set of requirements closely couples to the development of the architecture. Architecture embodies the breakdown of the system into subsystems, and the final system requirements development should consider the architecture. Many approaches to medical device development advocate for design inputs that are “concept free”, but a concept free approach can …
The operational risk analysis forms the basis for the use case development. During the operational and functional analysis portion of the risk analysis, use cases have been identified and linked to the failure modes. This analysis needs to be formalized into use cases that can be translated into requirements. In most definitions of a use …