MDD Audit

evan_kim90 · May 16, 2024

Hi, everyone

I got a schedule for the ISO+MDSAP and MDD audits at the end of July 2024.

1. Kindly anybody has kind of information gap analysis between ISO 13485:2016 and MDD so I can prepare more perfectly?
2. There is any special point have to be focus on for MDD audit?

Thanks in advance!

evan_kim90 · May 16, 2024

Hi, everyone

I am first time to do review standard for our devices and I am so confused how to do it.
So below 3 photos are each standards applied per device.

1. What is best option for doing gap analysis each standards?
2. If there is updated version of standards, should we buy standards each of them? or is there a way to see only what is updated?
3. Normally, where can we check the recent version of standards?
4. How can we double check the harmonized standards?
5. Any advice or teaching for gap analysis?

I know I have lot of questions but I really want to learn and want to do proper way.

Thanks in advance for helping and sharing!

Ed Panek · May 16, 2024

Im amazed MDD certificates are still being issued. Is that listed in the actual audit scope?

evan_kim90 · May 16, 2024

Ed Panek said:
Im amazed MDD certificates are still being issued. Is that listed in the actual audit scope?

Hi, Thanks for question.
Well, we did not get any plan from NB or scope but during face to face meeting they said, they will do MDD audit as well after ISO+MDSAP audit.

indubioush · May 16, 2024

evan_kim90 said:
Hi, everyone

I am first time to do review standard for our devices and I am so confused how to do it.
So below 3 photos are each standards applied per device.

1. What is best option for doing gap analysis each standards?
2. If there is updated version of standards, should we buy standards each of them? or is there a way to see only what is updated?
3. Normally, where can we check the recent version of standards?
4. How can we double check the harmonized standards?
5. Any advice or teaching for gap analysis?

1. A gap analysis is done by comparing the current requirement to the new requirement, and then determining the appropriate action required to comply. This is typically documented in record form. An auditor may ask you for this record.

2. Sometimes, there is a summary of changes on the website. Sometimes there is a redlined version, but you have to buy it. Sometimes you can look at a PDF preview of the document and they will show the summary of changes.

3. Create a "My Tracker" with ACCURIS (formerly Techstreet). You can also search for standards: Help Center

4. For MDD, see here: Implementing decision - 2020/437 - EN - EUR-Lex However, it states, "It shall apply until 26 May 2024." For MDR, see here: Medical devices

5. Example:

evan_kim90 · May 16, 2024

indubioush said:
1. A gap analysis is done by comparing the current requirement to the new requirement, and then determining the appropriate action required to comply. This is typically documented in record form. An auditor may ask you for this record.

2. Sometimes, there is a summary of changes on the website. Sometimes there is a redlined version, but you have to buy it. Sometimes you can look at a PDF preview of the document and they will show the summary of changes.

3. Create a "My Tracker" with ACCURIS (formerly Techstreet). You can also search for standards: Help Center

4. For MDD, see here: Implementing decision - 2020/437 - EN - EUR-Lex However, it states, "It shall apply until 26 May 2024." For MDR, see here: Medical devices

5. Example:
View attachment 30221

Hi, This information is helping me alot! Thanks! So, I checked some of them and it looks like there was multiple update... In that case, normally purchase recent one and do gap analysis?

indubioush · May 16, 2024

evan_kim90 said:
In that case, normally purchase recent one and do gap analysis?

This is kind of a tricky answer. There may be annexes in the EN (European) versions that you are required to follow. Also, the harmonized version may be an older version. In this case, you may be able to justify using the newer version since it could be considered "state of the art." In certain cases, it may be better to use an older harmonized version vs a very new ISO version. You should be safe if you follow the MDR harmonized versions.

You can also buy cheap standards here, but consider the number of user licenses you need: Search - EVS standard evs.ee | en

evan_kim90 · May 16, 2024

indubioush said:
This is kind of a tricky answer. There may be annexes in the EN (European) versions that you are required to follow. Also, the harmonized version may be an older version. In this case, you may be able to justify using the newer version since it could be considered "state of the art." In certain cases, it may be better to use an older harmonized version vs a very new ISO version. You should be safe if you follow the MDR harmonized versions.

You can also buy cheap standards here, but consider the number of user licenses you need: Search - EVS standard evs.ee | en

Okay.. Gap analysis is really new to me so it is really hard to thinking correctly but thanks for your help. So, if we do gap analysis and if we do not require any test or action, can we say newest version of standard is applied in our device?

indubioush · May 16, 2024

evan_kim90 said:
Okay.. Gap analysis is really new to me so it is really hard to thinking correctly but thanks for your help. So, if we do gap analysis and if we do not require any test or action, can we say newest version of standard is applied in our device?

You could make this claim if you did a gap analysis and there was truly no action needed. This could apply in the situation where there were only minor changes, or the section of the standard that changed does not apply to you.

MDD Audit

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Ed Panek

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indubioush

Ah ha!

evan_kim90

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indubioush

Ah ha!

evan_kim90

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indubioush

Ah ha!

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