Category «Product Design and Development»

Translating design inputs into the finished medical device

Building the Right Product Introduction

Building the right product involves the translation of user and business needs into a product concept

Basic Cybersecurity For Medical Devices

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 …

Verification Test Planning

Test design needs to determine the right test level, minimize test overlap and ensure full coverage

Agile Software Development for Medical Devices

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

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

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 …

Design Worksheet Development

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 …

Requirements Deployment

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

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 …