Quality Assurance
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Quality is key to everything we do at Tactiq. Many of the systems we develop are safety related whether they are medical, industrial, military or automotive. Even if they are not, then customers appreciate systems that are dependable and easy to use.
An old view of achieving quality is through inspection and test to make sure the product has been built and works as expected. Testing is important but test of the finished product breaks down with the sort of complex products that Tactiq develop. The development process and design must all support the achievement of a high quality result.
Tactiq is accredited to ISO 13485 for the development of medical devices. A formal quality management system that is audited internally and externally by a notified body helps ensure that we follow good quality processes and deliver systems to the highest levels of quality.
The V-model is used as a model of outputs and to support verification with a iterative/incremental development strategy particularly for software. This fits well with the regulatory requirements for medical and other devices. At the start of a project Tactiq identifies the key standards, technical and safety risks and creates an architecture and development plan to meet the needs of each project. This fits well with medical software for example where the regulatory requirements are based on the risks created by a software failure.
The standards for a device broadly fall into two categories product design standards that define rules and specifications that the product must meet and process standards that define the processes that must be used in the design and development. In both cases it is not just important that the standards are met but there is documentation to demonstrate that it is met so that we and a notified body can check that they really are met. Some key standards Tactiq are familiar with meeting are: