TGFR Consulting LLC Transforming Medical Device Development
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 …
Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs. The overall work flow is as shown in the following Over the next several weeks we will discuss each of the activities, starting with the use case development
Based upon the evaluation of risk, mitigation of the hazardous situations will be needed. In determining the need for risk controls, care must be taken to align with the requirements of ISO 14971:2012. The approach to risk control should be based upon the risk for a hazardous situation and can be summarized as follows This …
Identification of all the hazardous situations associated with the therapy or procedure requires the identification of all actions (both user and device) associated with the execution of the therapy or procedure. Use of functional analysis, rather than starting with the failure modes of the device and assessing risk of the linked therapy or procedure actions, …