Device History Record Database

Cogmedix maintains medical device history records (DHR) in accordance with the requirements of the 21 CFR 820.

Cogmedix Process

Cogmedix maintains medical device history records (DHR) in accordance with the requirements of the 21 CFR 820.  The Quality System at Cogmedix ensures that DHRs are maintained in accordance with the Device Master Record (DMR).  Cogmedix stores DHRs in a safe and secure location with an electronic back-up.

DHRs are uploaded on FTP sites for easy retrieval for our customers.

Device History Record Database

Cogmedix maintains a complete DHR containing dates of manufacture, quantities manufactured, quantities released for distribution, acceptance records which demonstrate the device is manufactured in accordance with the DMR, the primary identification label and labeling used for each production unit, and any device identification(s) and control number(s).
The DHRs will also include information on incoming material acceptance, on the manufacturing process, and on testing results that can be used to perform trend analyses.

A basic outline of what some of the documentation specifies includes the following:

  1. Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
  2. Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
  3. Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
  4. Packaging and labeling specifications, including methods and processes used; and
  5. Installation, maintenance, and servicing procedures and methods.

Device Master Record — Quality System

DMRs contain and/or reflect the approved device and process designs, are under change control, contain an approval signature of the customer, and are directed toward the intended user. These requirements are in the Quality System regulation because the DMR is the “beginning and end” of a product.

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