We have a medical device business engaged in product development only (no manufacturing, etc), and we want to earn a QMS certification. What is the best path? If ISO 13485, what exclusions? Does anyone have real-life experience with this scenario?

All replies are appreciated!

Patricia

We have a medical device business engaged in product development only (no manufacturing, etc), and we want to earn a QMS certification. What is the best path? If ISO 13485, what exclusions? Does anyone have real-life experience with this scenario?

All replies are appreciated!

Patricia

Patricia,

I moved your post to the ISO 13485 Forum.

Please do not post duplicate messages.

Stijloor, Moderator.

Product Development for medical devices covers a whole host of things, you should probably be specific:


If clinical: probably some kind of CRO certification.

If labwork: probably ISO13485 and/or ISO17025

If outsourced (contract) engineering design: probably ISO13485

If software design - probably ISO13485 and TickIT


And the list goes on.....

A couple more bits of information would be useful:

Are you developing the product for someone else to sell?
Will it have your company name on the device?
Which global market is the product destined for?
Do you know what risk classification the product is (under the rules of which countries regulations)?

More detail: We make Class IIa medical devices (non invasive, low risk) associated with the MRI industry. The designs are developed for OEM (Philips, etc), and carry their name. Sometimes we develop an item that carries our own name (direct sale).

We do not manufacture the devices - we develop the designs, and someone else manufactures them. If the manufacturer or customer wants a design change once production has begun, we make the appropriate changes, recording DCN and deviations.

So - if we certify to ISO 13485, what exclusions might we employ? Is it even possible to certify with exclusions, or is there another path we may take? The finished products are sold worldwide, but the manufacturer is certified to ISO 13485 and the MDD (notified body is TUV CE0123).

:thanks:
thank you for your response,

patricia

Based on direct experience, I would think that ISO 13485 would be your first tier MRI customers' expectation of you, as a Supplier to them.

Whether any exclusions might be permissable and desirable would depend on the details of what you do to and with the finished products. If you package and label product for fulfillment of orders for products sold under your own name, for instance, that might amount to a (small) manufacturing activity of your own.

Under your circumstances, I wouldn't regard exclusions as a key focus. Having a full-fledged quality system does give you operational flexibility as you grow and deal with changing circumstances and sudden customer needs.

Presumably you want the ability to apply the CE Mark to those products that you sell under your own name. You refer to the fabricator of the devices as the manufacturer, but actually for the devices that you design for sale under your own name, you are the Manufacturer and they are a Supplier to you. As the marketer of those devices, you have full regulatory responsibility, including for their fabrication operations on your behalf and to your specifications. Thus you should move toward having your own CE Mark on those products.

I assume that "worldwide" sales eventually might include the US market. Thus you may also want your QMS to conform to the somewhat different requirements of 21CFR820 and the other FDA rules. That, however, could be an additional layer on top of your 13485-based QMS.

The products you sell under your own name, as MRI devices, might be FDA Class II. As such, they would require 510(k) premarket notifications. I'd guess you'd also want them to be qualified and marked for the FDA's new MRI Safe requirement.