Justification for Exclusion of Design and Development

J

jennaleeb

Hiya! Thanks to everyone who provides such valuable insight in this forum.

We are a small medical device company (1 product, 4 employees) and manufactures a device that is Class I sterile in the EU and Class II in Canada. We outsource all manufacturing processes to another ISO certified company.

We are in the process of setting up our quality management system and it has come to my attention that CAN/CSA-ISO 13485 permits manufacturers of Class II medical devices to exclude clause 7.3 - Design and development from the QMS, with justification(s), and Annex V of the MDD requires only production quality assurance system.

What does "justification" mean? Does anyone have an example? I assume "is not required by markets the product is sold in" is not good enough.

Thanks!
 
T

t.PoN

I get that you don't do design of whatever sort, right? if that is the case then it would be quite simple.
A statement "The design process Clause 7.3 doesn't apply in your company scope and activities" will do the trick.
just make sure that the scope of quality manual is clear. for example "Manufacturing, distributing, ...etc"

but if you do a design, then it would depend on the process and the product
 
J

jennaleeb

Thanks for your response t.PoN!

My confusion arises because we DO do design...but we design a product that is Class I (EU) and Class II (Canada) and these markets permit exclusion of design for these device classes.
 
T

t.PoN

This is a point of view from ISO 9001, and not ISO 13485

What is the impact of design on final product and the customer? who claims responsibilities of the design? if there is effect, then i don't think you can exclude Design, even if the EU regulation doesn't have a design requirements.

it all goes back to the impact on product, and customer.

if it has none, then you can exclude it.

The popular example: the design is given to you by customer, then you can exclude design.

Another example: you have a product A that has been designed and being manufactured for a long time. there is no change in design. but you also have a research and development that design a new product B. you can exclude design but the scope should be on Product A and not product B.

what is your case exactly? why do you need to exclude design?
 
M

MIREGMGR

You can only exclude activities from your QMS that you in fact do not do.

So: you don't need to have a servicing procedure if you don't have any products that require servicing.

But if you manufacture products, or arrange for someone else to manufacture them, someone had to design them. Either you have to be responsible for that design, or you have to control via procedures in your QMS the activities of whoever you contract with to do that design on your behalf.
 
J

jennaleeb

Okay - so I suppose I was reading the regulatory standards incorrectly.

I was reading "in Canada For Class II devices the scope can exclude design.." as "this part of your QMS wont be audited". But I guess what it really says is "you can exclude design if you actually don't design anything".

Since we are responsible for design, we cannot exclude it.

Thanks everyone!
 
S

silentrunning

Jennaleeb, who does the validation of your product? If it is of your design, does your company validate it?
 
J

jennaleeb

Hi silentrunning,

Hmm, I suppose yes it is us. We have a very simple device, essentially a specimen collection device. We are part of some ongoing clinical trials that are investigating self-collection of vaginal samples. Our subcontracted manufacturers validate the sterilization process.

Is this what you mean?
 

Ajit Basrur

Leader
Admin
As per 21 CFR Part 820.30, only select Class I medical devices need to have Design Controls (see below) and if your device is not in the list, you can justify the exemption.

Design Controls apply only for the following Class I devices -

(i) Devices automated with computer software; and

(ii) The following devices -

Catheter, Tracheobronchial Suction.
Glove, Surgeon's.
Restraint, Protective.
Applicator, Radionuclide, Manual.
Source, Radionuclide Teletherapy

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.30
 
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