Automation of high integrity development

A medical device must meet a range of regulatory requirements, which define both specific requirements for a class of device and procedural factors that govern the design, development and manufacturing processes. The latter pay especial attention to quality issues that ensure that responsibility for decisions right through the production cycle is clear and can be recovered in a subsequent audit.

We use a suite of automated tools customised to benefit development of medical devices and all products that must conform to a regulated or quality-driven framework.

Traditionally, these tasks have been formulated using paper-based systems. However, the automated technologies that we employ can be configured to provide the required information for auditing automatically. The processes followed and responsibilities for decisions are still defined in a manner compliant with regulatory demand but the overhead of paper-based systems is substantially reduced.

  • We use a high-quality requirements management tool, which ensures that tracing between requirements is carried out in a dynamic environment. It is well-known that requirements need to be modified as experience increases during development. The effort in maintaining tracing through the development cycle using a paper-based system can easily become prohibitive. Properly undertaken tracing, which can be sustained throughout the development cycle mitigates against expensive late design changes by helping problems to be identified in a timely manner.
  • Our use of Model-Driven Development (MDD) software tools provides a straightforward means to build systems quickly and reliably. We test models to identify any difficulties encountered in specifications at the earliest opportunity. Modifications necessary for engineering or usability reasons, are made before resources have been committed to an intractable development. The MDD tools provide automated generation of code for almost all types of computer system - including the smallest with no operating system and few facilities.
  • We automate change management through the use of best in class tools. Regulation demands that a clear process is used for design changes: the process may be enacted in a tool that ensures that specified individuals manage critical parts of the life cycle. The tool is able to create both comprehensive audit trail information and enforce that electronic signatures to 21 CFR 11 are employed.
  • We have customised procedures for an automated change management system, which may be deployed in Post Market Surveillance. By integrating a reporting system for customers with the change management system that drives development, an engineering manager may gain a full view of how a product is behaving in the marketplace alongside routine development effort.

Automation is of little benefit if it is not flexible. There is little point in changing tried and tested development practices. However, there is often a rapid return on investment in the application of automation to established quality systems in terms of staff time saved and the greater availability of information that may inform how design and development tasks may be further optimised.

We help companies to introduce and integrate these techniques and tools by mentoring in their use and customising tools to comply with specific demands. We undertake work using these tools to maintain the high standards required for medical devices whilst reducing development time.