Establishment of device history records (DHR) is one of the last steps in the compliance process for medical devices. It falls under subpart M of 21 CFR Part 820, which deals with general record-keeping requirements for medical device companies. Manufacturers are subject to this part whether they keep records on paper, or they use a web-based software QMS to manage documentation. The DHR serves as a production record for medical devices that you manufacture - entries into this document include acceptance records for individual units or batches of product, along with product counts, labels, and any unique product identifiers that have been applied.
The requirements for documentation in the DHR can be found in 21 CFR Part 820.184, but for your convenience, we've included them below:
Most sections of 21 CFR Part 820 refer to establishing overall quality processes that affect your product design and manufacturing, but the DHR is different in that it is applied to each batch of products that you produce. The DHR mandate requires that new batches of product are tested to ensure that they meet the product specifications established in the device master record. The mandate also ensures that batches of product are correctly labeled and assigned identification numbers. This creates traceability throughout your supply chain, enabling you to better identify sources of error in case any non-conformance issues arise with your products.
The DHR plays an important role in the quality system at your medical device company. Here are a few ways that companies are leveraging the DHR to improve their processes, get better results, and stay compliant with the latest standards and regulations:
DHR is a living document - it should be updated each time you manufacture a new batch of product with unique device identifiers and conduct tests against your acceptance criteria for the new batch of product. Greenlight QMS uses built-in document controls to ensure that your important records never get lost or deleted, and you can easily update your DHR with each new batch of medical devices that you release for distribution.
The DHR mandate also allows for linking between documents, so you'll be able to include links to the full results of acceptance testing within your DHR. Having all of your information in one place makes the audit process go smoothly and will save you time and money when applying for ISO certification or dealing with an FDA audit.