Differences between ISO 13485 & FDA Requirements

[Vthouta]

Hi,

Can anyone in the forum could help me in educating and understanding the differences between the requirements of ISO 13845 & FDA.

My firm manufactures class-II medical devices and we comply to ISO 13485 requirements strictly.

So, as a supplier if we meet all of the ISO 13485 requirements. Does that mean we will indirectly satisfy the customer fda requirements.

Thanks in advance for posting your replies.

 

[Marc]

Start here: Differences between ISO 13485 & FDA Requirements

 

[MIREGMGR]

So, as a supplier if we meet all of the ISO 13485 requirements. Does that mean we will indirectly satisfy the customer fda requirements.

This is a simple-seeming question with a potentially complicated answer for which we don't have enough information. It's also not clear what you mean by "indirectly satisfy".

Start with the document linked by Marc. If/when you want to go beyond that, you'll need to learn, or engage the assistance of a consultant who knows the details of, the particulars of FDA's rules and guidances pertaining to your device type.

 

[somashekar]

So, as a supplier if we meet all of the ISO 13485 requirements. Does that mean we will indirectly satisfy the customer fda requirements.

The title of the ISO13485 is "Medical devices - Quality management systems - Requirements for regulatory purposes"
So how you can meet ISO13485 requirements is when you know that your devices are going into the USA and therefore you have to meet the FDA requirements, which is the regulatory.
The ISO13485 is an international standard
The FDA is regulating medical devices in the USA
There may be many things in common, but please do not look for differences. The regulations can have some additional.
Look for additions in the FDA over and above the ISO13485

 

[Vthouta]

Thanks for posting your replies and also sharing your experience.

The hyperlink posted by Marc was really helpful to clarify all of my illusions on the requirements for FDA & ISO 13485.

Even though the question is simple, the answer is bit complicated.

Does that mean we will indirectly satisfy the customer fda requirements? I was assuming that if any company meets ISO 13845 standard, then it automatically meets all the regulatory requirements of FDA that are required for a manufacturing medical device unit.

 

[MIREGMGR]

Does that mean we will indirectly satisfy the customer fda requirements? I was assuming that if any company meets ISO 13845 standard, then it automatically meets all the regulatory requirements of FDA that are required for a manufacturing medical device unit.

Someday if "harmonization" has made more progress, that may be true. For now, there are similar goals but different pathways to get there.

 

[Marcelo]

If you are talking about the QMS requirements of the FDA (not all applicable requirements, only 21 CFR 820 - the QSR):

The QSR was created based on old versions of ISO 9001 and ISO 13485 (prior to 1996).

Those standards were a bit more prescriptive than ISO 13485 today, meaning, they had more detailed requirements, although the general expectations were the same.

In my experience, if you comply with ISO 13485 but do not know the more specific requirements in the QSR, you will not comply with QSR specificities, even being compliant with ISO 13485.