T
Triboyle
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
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