WHAT IS 21 CFR PART 820?

21 CFR Part 820 is a set of regulations from FDA that offers current good manufacturing practice
(CGMP) requirements. These CGMP requirements ensure medical device companies establish a QMS
that enables them to deliver safe, effective, and compliant products

“the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished
devices intended for human use,” including the facilities and designs used for those processes

. It consists of 15 subparts

Validation means confirmation by

examination and provision of objective

evidence that the particular requirements for a specific intended use can

be consistently fulfilled.

(1) Process validation means establishing by objective evidence that a

process consistently produces a result

or product meeting its predetermined

specifications.

(2) Design validation means establishing by objective evidence that device specifications conform
with user

needs and intended use(s).

Verification means confirmation by examination and provision of objective evidence that specified
requirements have been fulfilled

Validation means confirmation by examination and provision of objective evidence that the
particular requirements for a specific intended use can be consistently fulfilled.

Verification:

Purpose: Verification checks if you built the product right (measuring against specifications).

When: It happens during the design and development phase.

Activities: It involves testing and checking to meet design specifications.

Outcome: It confirms the product matches its design on paper.

Validation:

Purpose: Validation checks if you built the right product (meeting user needs).

When: It occurs after the product is made and used in real-life situations.

Activities: It involves real-world testing to ensure the product works as intended for users.

Outcome: It confirms the product meets user expectations and works effectively in its intended
environment.

Design controls.

establish and maintain procedures to control the design of the device in order to ensure that
specified design requirements are met.

Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device
design is correctly translated into production specifications

Design changes. Each manufacturer shall establish and maintain procedures for the identification,
documentation, validation or where appropriate verification, review, and approval of design changes
before their implementation

1. DHF (Device History File): The Device History File is a comprehensive record that
contains all the documented information related to the design, manufacturing, and
quality of a medical device. It includes design inputs, verification and validation records,
manufacturing processes, inspection results, and other essential data. The DHF serves as a
historical reference for the entire lifecycle of the device and is a key document during
regulatory audits.
2. DHR (Device History Record): The Device History Record is a collection of documents
and records specific to the production of an individual batch or unit of a medical device.
It includes details about the manufacturing processes, quality control checks, test results,
and any deviations or non-conformances encountered during production. The DHR is
created for each device to provide a traceable history of its manufacturing.
3. DMR (Device Master Record): The Device Master Record is a compilation of all the
documents and specifications necessary for the consistent and accurate production of a
medical device. It includes information such as design specifications, production
processes, quality control procedures, labeling requirements, and any other relevant
details. The DMR serves as a reference for ensuring that each device produced adheres to
the approved design and quality standards.