MedTech Manufacturing worked example

Device History Record Time at 18% review and approval allowance: a worked example

Here is what the math looks like when conditions slip. We hold every other input steady and drop review and approval allowance to 18%, then walk the calculation through step by step. Estimate time to complete Device History Record (DHR) documentation per production lot including entries, review, and approval.

The inputs for this scenario

  • DHR entries per lot: 45 entries (held at the documented default)
  • Entries completed per minute: 1.5 entries / min (held at the documented default)
  • Review and approval allowance: 18 % (the input this scenario stresses; the baseline uses 25)

Working through the calculation

  • The calculation starts from the formula this tool documents: Base device history record time = DHR entries per lot รท entries completed per minute.
  • Total DHR completion time works out to 35.4 min at these inputs, and this is the headline figure for the scenario.
  • Base documentation time works out to 30 min at these inputs.
  • Review and approval time added works out to 18 % at these inputs.
  • Documentation entry rate works out to 1.5 pieces / min at these inputs.

How this compares with the baseline

  • Against the tool's baseline example, where review and approval allowance sits at 25% and the headline result is 37.5 min, this scenario comes in 5.6% below the baseline at 35.4 min.
  • The practical read: the gap between this scenario and the baseline is entirely attributable to review and approval allowance, so recovering it is worth quantifying in dollars before considering equipment or staffing changes. It assumes a steady entry rate and a flat review percentage; complex exception handling, deviations, or missing-data chases can add far more time than the allowance covers.

Results at a glance

  • Total DHR completion time: 35.4 min (headline result)
  • Base documentation time: 30 min
  • Review and approval time added: 18 %
  • Documentation entry rate: 1.5 pieces / min

Run it with your numbers

  • To rerun this with your own numbers, open the live Device History Record Time calculator, set review and approval allowance to your actual value, and adjust the remaining inputs to match your operation.

Last reviewed 2026-05-12.