ISO:13485 Strategy for a Startup

[AdotBdot]

Hi all, we are new medical device startup based in New Zealand. We are currently only planning to sell in New Zealand and want to enter the Australian markets maybe next year. We are planning to get our ISO:13485 and I had a few questions.

1. We are planning to exclude design from the scope and wondering if we would still require a DHF? NZ has no recommended regulatory requirements as such.

2. My understanding is that we essentially require a Device Master Record and Device History Record which can become our medical device file.

Is my thinking, right? or am I missing something here?

 

[Apoorva]

Hi Adotbdot,

The ISO 13485 certification is applicable to organisation which will create the manufacturing of the product. However, the product quality compliance is driven through the manufacturers quality standards. The technical file requirements is not based on ISO 13485 it is based on the classification of the product.

In Australia the technical file requirements are based on the risk class of the device.

If you had anu further questions and need any support please write to REDACTED to remove solicitation of business

 

[yodon]

We are planning to exclude design from the scope

What's the basis for this decision? (Not saying it's necessarily wrong.)

The terms DHF and DMR are FDA QSR terms, not 13485-based terms. You're not incorrect, though, in applying the concepts.

BUT, the design history is important if you ever need to make changes. While it may not be required for any submissions, you may want to maintain that information for maintenance / enhancements purposes.

 

[Chrisx]

Not sure about New Zealand, but in the EU you can't exclude design if the conformity assessment route is Annex II.3 under the MDD. I think it is similar under the MDR. The EN version of ISO 13485 has an annex that explains which conformity assessment routes permits which exclusions of ISO 13485. It would seem like it would be similar for New Zealand and Australia, since Australian regulations are similar to EU. However, I'm not completely certain.

 

[AdotBdot]

What's the basis for this decision? (Not saying it's necessarily wrong.)

The terms DHF and DMR are FDA QSR terms, not 13485-based terms. You're not incorrect, though, in applying the concepts.

BUT the design history is important if you ever need to make changes. While it may not be required for any submissions, you may want to maintain that information for maintenance / enhancements purposes.

The basis is that we did not have a QMS in place when we designed it and do not have the resources (time and HR) at this stage to go back and get it completed. Hence want to exclude design and get the QMS certificate and get sales and then go back and get the Design part done during the next mid audit.

But for the audit we do need a medical device file and was wondering if just the device manufacturing records and device history records would be enough to complete them.

 

[yodon]

As @Apoorva pointed out above, the answer is going to be tied to the device classification. I don't know NZ regs so I can't say with any certainty.