This international standard specifies requirements for a quality management system in which an organization needs to demonstrate its ability to provide medical devices and related services consistently meeting customer needs and applicable regulatory requirements.
Requirements of this international standard apply to organizations, regardless of size or type, unless explicitly stated otherwise. In all cases that requirements are specified as applicable to medical devices, those requirements apply equally to associated services supplied by the organization.
Device History Record
What is Batch Production Record?
Device History Record, also is known as DHR, is the methodology employed to ensure high quality manufacturing processes in the medical device industry. The DHR process demonstrates how each specific device was manufactured, according to the design specifications. The process also includes all the tests and results which were made to ensure high quality.
Why do we need it?
How does it help me?
Use and adoption of Dot Compliance Suite ensures high-quality production and compliance throughout manufacturing processes. Our simple and easy to use cloud interface ensures each device is manufactured according to the Device Master Record, along with assessing and ensuring all required tests have been performed successfully.