Device master record: the recipe somebody else has to follow

A device master record is the compilation of procedures and specifications for a finished medical device: what it is, how it is made, how it is checked, how it is packaged and labelled, and how it is installed and serviced. Where the design history file records how the design came to be, the device master record states what the device now is and how to produce it.

The practical test is whether a competent manufacturer who has never seen the device could build it correctly from the record. That is not rhetorical — it is what happens when production moves to a contract manufacturer, a second site, or a new team after the original engineers have gone.

What a device master record covers

• Device specifications: drawings, composition, formulation, component specifications, software specifications.
• Production process specifications: equipment, methods, procedures, production environment specifications.
• Quality assurance procedures and specifications, including acceptance criteria and the equipment used.
• Packaging and labelling specifications, including the methods and processes used.
• Installation, maintenance and servicing procedures and methods, where applicable to the device.
• And for each of these, the document identifier and revision — because the record is largely a set of pointers.

Pointers rot

Because a device master record mostly references other controlled documents, its integrity depends entirely on those references staying valid. A drawing revised without updating the record, a procedure renumbered during a system migration, a specification withdrawn and replaced under a new identifier — each leaves a pointer to something that no longer exists as cited. The failure is silent until somebody tries to use the record for its purpose, which is usually the worst moment. Reviewing the reference list against the document system on a schedule is dull and is the whole job.

Keep the device master record and the production records distinct. The master record says how the device is made; the history record for a given batch says how that batch actually was made. Conflating them makes it impossible to answer either question — what should have happened, and what did.

Transfer is where it is tested

Design transfer — moving from development into routine production — is where the quality of the record becomes visible. If manufacturing has to ask the design team questions that the record should answer, the record is incomplete, and that is the moment to fix it rather than to answer the questions verbally. The same applies to any subsequent transfer to another site or supplier: treat the questions asked as a defect list against the record.

Keeping it consistent

Ettex Sheets holds the index of specifications and procedures with their current revisions, so a stale reference is visible rather than latent, and Ettex Records keeps the compiled record per device with its approval history. The design-side compilation is covered in design history file, and the underlying product structure in bill of materials.

Plainly: this is a spreadsheet and records approach, not a regulated document control system, and none of it is regulatory advice. Terminology and structure in this area are being aligned to the international standard and should be checked against the current rule.