Manufacturing and Quality Assurance in Compliance with the MDR and IVDR

Abstract

Medical devices and in vitro diagnostic medical devices must be designed and manufactured in such a way that they are fit for their intended purpose and achieve their specified performance under normal conditions of use over the lifetime of the product. The prerequisite for achieving this result is that the relevant regulations and technical standards are complied with during the development of a product and that the defined performance criteria are proven by means of internal and external evaluations. In addition, appropriately designed and qualified production, testing, storage, and transport facilities and equipment must be available and their valid condition must be continuously monitored and maintained. The following chapter describes how the manufacturing and quality assurance processes must be designed to meet the legal requirements and to ensure that the specified performance criteria are achieved with a high probability during series production. In particular, this chapter describes how tests are to be carried out in the incoming goods, the process, and the final inspection department, which records are required in production, and how the current product status can be marked and traced in order to enable a fast steering of defective products in the event of a fault. In general, this chapter provides an overview of the essential steps and requirements with regard to planning, implementation, and documentation for manufacturing processes according to European as well as international regulations and standards. Special emphasis is put on the requirements for the management of test equipment, working environment, employee qualification, packaging, labeling, storage, transport, installation, and service. Practical tips and information may provide start-ups and young companies in particular with an overview of how to plan a manufacturing process that not only meets the regulatory requirements, but also delivers products with the expected quality and at the planned costs with a high degree of certainty during series production.