Are Capability Studies a regulatory requirement ?

HI Guys,

Are Capability Studies a regulatory requirement ?
I am referring to the Medical Device Industry

Appreciate some advice and guidance
thank You

 

Probably need a little more background. For devices, you have to establish efficacy (it does what you claim it does). This is often through a comparison to a predicate device and established through validation testing or clinical trials. Might you be referring to usability? That's certainly getting more focus in both US and EU. IEC 62366 is the consensus standard for that. If you put a device through the latest release of IEC 60601 testing, then they require evidence of compliance to this standard.

 

Hi Yodon , thanks for reply
Capability Studies , i mean eg; Process Performance asessment as part of validation periodic review.
medical devices eg stents etc

 

Hiya Atul,
Havent a clue what the poll options Prompt was supposed to be for
I just couldn't submit the post , without entering something for it.

 

Going back to the original question, there are no regulations that require a capability study be performed. This is one of many methods that can be used depending on the work being performed. I believe the only regulatory requirment is that valid statistical techniques be used and sampling plans based on a valid statistical rationale (21CFR820.250 or ISO13485:2016 7.3.6).

 

thanks for reply
Sorry Bev D, I don't understand what you mean ?

 

Hi Vintage Goose -thank you for your reply

Just querying - Is ISO13485:2016 7.3.6 not more applicalbe to Statistical Methods for Determining Sample Size to complete the initial validation of a process.
IE : Deciding which statistical techniques to use is dependent on the type of data for which validation is required & deciding on which type of data: variable and attribute.
I'm querying the process control and performance assessment aspect and how to complete review and assessment to provide evidence of validated state being maintained. and in that context, the use of capability studies for this purpose of maintaining a validated state ???

 

Hi, you may be correct, when I see the phrase Capability Study I think of initial validation, whereas for ongoing process control, I think of Process Capaibility. The reality being they are largely the same thing!

To show that the process is maintaining the validated state, I would start with a SPC Control chart to show that the process is in control, then use capability to show how controlled you are.