Post-market support

What has to keep running once the device is sold. Complaints are recorded, investigated and closed, and what they reveal feeds the next build.

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When post-market support is the right step

From the first unit sold. Complaints and device history records are how a quality system learns what the device does in real use.

Handle complaints
Each complaint logged, investigated and closed, with a decision on whether it must be reported.
Correct and prevent
Corrective and preventive action that finds the root cause and checks that the fix worked.
Keep device history records
A record for each batch or unit, so any unit can be traced to its parts and its build.

What you bring, and what you get back

You bring

The device master record and labelling
Complaint and service records so far
The risk management file
The markets where the device is sold
Open corrective actions and nonconformances

You get back

A complaint handling process and a complaint log
Investigation records and reportability decisions
Corrective action records, with root cause and effectiveness checks
Device history records for each batch or unit
Trend reports on complaints
Proposed updates to the risk file when field data changes it

A complaint is a design input

A complaint closed with only a reply to the customer has taught nothing. Under ISO 13485, complaints are investigated, trended and fed to corrective and preventive action. When the root cause is in the design, the fix goes through design change control, and the risk file kept under ISO 14971 is updated with what the field showed.

How post-market support runs

Step 1
Set up the process
Complaint, reporting and corrective action procedures fitted to the device.
Step 2
Log and investigate
Each complaint recorded, linked to its batch and investigated.
Step 3
Decide on reporting
Each complaint assessed against the reporting rules of the market.
Step 4
Correct and prevent
Root cause found, the fix made, and its effect checked.
Step 5
Keep the records
Device history, complaint and corrective action records kept traceable.
Step 6
Review the trends
Complaints and feedback trended, and the risk file updated.

Questions buyers ask

Which events must be reported to the regulator?

Serious adverse events and field safety actions, within set time limits. In India, the materiovigilance programme covers devices on the market. In other markets, the local vigilance rules apply. The investigation records the decision either way.

What is a device history record?

The record of how a batch or unit was built: quantities, dates, component lots, inspection results and release. It lets you trace any unit in the field back to its build.

Does corrective action only follow complaints?

No. Audit findings, nonconformances, supplier problems and trends can start one too. The aim is to find the cause and stop it happening again.

How long must records be kept?

ISO 13485 asks for at least the lifetime of the device as the manufacturer defines it, and not less than two years from release, unless local rules ask for longer.