Customer Requirements for Single Use Medical Devices

#1
Dear all,

I new to medical devices industry, I planning to design a Customer requirement for our medical devices, kindly share some template which will be helpful for me.

Please let me know Surgical textiles have Design control requirements as standards

Regards,
Muzammil
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
I'm not sure what the nature of your products is...most regulatory requirements apply to finished devices, not raw materials like fabrics...but if you make surgical drapes and covers, for instance, and if your marketing is primarily outside of USA and Canada, EN 13795 might be an applicable standard for you.
 
#3
Hi Marc,

Thanks for your reply.
Yes, we are manufacturer of Surgical gowns and drapes.
We make custom made Surgical kits as per customer requirement and I want to capture all these requirements before we start our production lot, so at the end product release I can compare the customer requirement and produced product is same as stated by the customer. So we will have confidence in the product release.

Does design requirement is applicable for our product as per CE or USFDA guide lines??
:thanks:
regards
Muzammil
 
M

MIREGMGR

#4
EN 13795 is generally applicable for marketing of drapes and covers within the EU, and elsewhere that the CE Mark is referenced.

There is no exactly parallel document for US FDA. FDA has a guidance for surgical gowns and drapes, though it's quite old and cannot be literally applied because so many of its provisions are obsolete. The similar performance standard under FDA is ANSI/AAMI PB70.

My guess would be that your primary design requirement is what your customer specifies they want to buy. The above standards however might be helpful in interpreting what your customers mean when they cite a particular performance level.

If your products are marketed in locales where US FDA regulations apply or the CE Mark is required, I'm surprised that you don't already know about these very basic regulatory requirements for your particular product types.
 
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