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Sample Retention Requirements - Quality Records procedure - ISO13485

T

Triboyle

#1
Hello all,
just a quick query.l am writing up a control of Quality Records procedure and under the heading of sample retention, i have hit a block.
We are a start up medical device company and as of yet, have no samples to retain. Is there a requirement to retain a certain amount of samples, when the device is a disposable, transient use, class 1 device (or class 2a MDD)? I know there are regulations around length of time for document retention, but are there any for sample retention? Should it even be in a control of records procedure?

Many thanks in advance,
Tri:)
 

QA-Man

Involved In Discussions
#2
ISO 13485 says "The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements"

It would be a good starting point to define the expected lifetime of the device.

I would take the greatest lifetime of all your devices and add a year or two to make things easy.

We're also a startup and use the following retention times. Note: The numbers are actually based on Japanese MHLW requirements

Physical copies of records are maintained for a minimum of 3 years. If there is no electronic equivalent the following applies:
  • Records related to personnel, training, and human resources will be maintained for 6 years
  • Records related to devices will be maintained for 16 years or the life of the device, whichever is greater.
Electronic records are maintained indefinitely
 
T

Triboyle

#3
:thanx:
ISO 13485 says "The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements"

It would be a good starting point to define the expected lifetime of the device.

I would take the greatest lifetime of all your devices and add a year or two to make things easy.

We're also a startup and use the following retention times. Note: The numbers are actually based on Japanese MHLW requirements

Physical copies of records are maintained for a minimum of 3 years. If there is no electronic equivalent the following applies:
  • Records related to personnel, training, and human resources will be maintained for 6 years
  • Records related to devices will be maintained for 16 years or the life of the device, whichever is greater.
Electronic records are maintained indefinitely
Many thanks for that. Does your quality record procedure include sample retention? If so, do you retain samples for the same length of time as your paper records?
 
T

Triboyle

#5
Yes, i have seen in other Control of Quality Records procedures for medical device companies that samples of each batch are held in case of testing needs later?
It seems an unusual place to store such instruction though and i cannot seem to find any regulation that requires it?
 

QA-Man

Involved In Discussions
#6
There are no regulatory requirements governing this (that I'm aware of).

Its not a bad idea to keep product samples but it might be impracticle. How many samples would you retain for each batch. How big are your products? Do you have the room to store them all for the life of the device?

You should absolutely define the controls and retention periods for all records related to the product. This includes design history records (shop/production travelers), manufacturing methods (work instructions), testing methods (incoming, in-process & final), operating procedures, labeling, instructions for use, traceability records, etc.

This way you can build a snapshot of the product at any point in time for any given batch.
 

Roland Cooke

Quite Involved in Discussions
#8
Records can of course include physical samples (often kept for re-testing in the event of a future complaint investigation being required).

Lifetime may actually mean a person's lifetime, in the case of certain implants.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#9
Typically you keep a device (on stability or sample retention) until a specified time past the expiry of the device. I have seen it as one year past the expiry date of the device.
 
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