Device History Record (DHR) in Medical Devices

Hello folks✌

In the previous blog, we explored the Device Master Record (DMR), the document that tells manufacturers how a medical device should be built.

But here's an interesting question:

👉 How do we know that a particular batch of devices was actually manufactured according to those instructions?

Having a recipe is one thing.

Proving that you followed the recipe is another.

That's where the "Device History Record (DHR)" comes in.

What is a Device History Record?

Think of DHR as the manufacturing diary of a medical device.

While DMR tells us what should happen, DHR records what actually happened during production.

In simple words:

👉 DMR = Manufacturing Instructions

👉 DHR = Manufacturing Evidence

Every production batch gets its own DHR.

Why is DHR Important?

Imagine a hospital reports an issue with a device.

The manufacturer needs answers:

  • Which batch produced it?
  • Who assembled it?
  • Were all inspections completed?
  • Did the device pass testing?

Without DHR, finding these answers becomes extremely difficult.

With DHR, everything is documented and traceable.

A Simple Real-Life Example

Let's say a company manufactures:

500 ECG Devices

Before shipping them, the company performs:

✔ Functional testing

✔ Quality inspection

✔ Packaging verification

✔ Label verification

All these activities are recorded in the DHR.

Months later, if a complaint arises, engineers can quickly review the production history.

What Information is Stored in a DHR?

Typically, a Device History Record contains:

👉Production Information

  • Batch number
  • Manufacturing date
  • Quantity produced

👉Testing Records

  • Inspection results
  • Functional test reports
  • Calibration records

👉Personnel Information

  • Operator details
  • Reviewer approvals

👉Packaging Information

  • Label verification
  • Packaging checks

👉Release Information

  • Final approval for shipment

Understanding DMR vs DHR

Many beginners get confused between these two.

A simple way to remember:

DMR

"What should be done?"

Contains manufacturing procedures and specifications.

DHR

"What was actually done?"

Contains records of the manufacturing activities.

Think of it like this:

DMR = Recipe Book

DHR = Cooking Record

A Small Industry Example

Suppose a production batch contains:

  • Total devices manufactured = 100

After testing:

  • Passed devices = 98
  • Failed devices = 2

Yield Calculation

Yield (%) =

(Passed Devices ÷ Total Devices) × 100

= (98 ÷ 100) × 100

= 98%

This information becomes part of the DHR and helps companies monitor manufacturing quality.

Why Regulatory Auditors Check DHR

During audits, regulators don't just want to see the design documents.

They want proof that:

✔ Devices were manufactured correctly

✔ Quality checks were completed

✔ Deviations were handled properly

✔ Records are available for every production batch

This is why DHR plays a critical role in compliance.

Final Thought 

A medical device doesn't become trustworthy simply because it was designed well.

It becomes trustworthy when every manufacturing step is properly documented and verified.

The Device History Record (DHR) provides that confidence by creating a complete record of what happened during production.

In the next blog, we'll explore Quality Management Systems (QMS) using ISO 13485 and understand how medical device companies build a culture of quality throughout the product lifecycle.

Stay tuned for the next article on MedTech Learning Hub✌

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