Getting Started - ISO13485:2003 and MDD (Medical Device Directive)

I am a newbe to both ISO13485:2003 and these forums. Firstly thanks heaps for the valuable information contained in this forum that I have been reading prior to registering. Secondly I have been asked to Setup ISO 13485:2003 and have a medical device CE marked - I am in Australia. I have all the standards and have read them so can some one suggest the steps or what order you would tackle it from the beginning considering our product is about 90% complete. The product contains a user interface by means of a software driven touch screen and various other mechanical / electrical components.

My background is not Medical or Qa but rather Documentation/Training and procedure/ process design so I may ask a few more painfull questions.

Thanks Heaps......

DAMAS said:

I am a newbe to both ISO13485:2003 and these forums. Firstly thanks heaps for the valuable information contained in this forum that I have been reading prior to registering. Secondly I have been asked to Setup ISO 13485:2003 and have a medical device CE marked - I am in Australia. I have all the standards and have read them so can some one suggest the steps or what order you would tackle it from the beginning considering our product is about 90% complete. The product contains a user interface by means of a software driven touch screen and various other mechanical / electrical components.

My background is not Medical or Qa but rather Documentation/Training and procedure/ process design so I may ask a few more painfull questions.

Thanks Heaps......

Click to expand...

Welcome.

Have you looked at the MDD (93-42) or ISO 13485 yet? If not look at the requirements in both those documents. Does your company have a "Quality or Business" System in place now?

DAMAS said:

I am a newbe to both ISO13485:2003 and these forums. Firstly thanks heaps for the valuable information contained in this forum that I have been reading prior to registering. Secondly I have been asked to Setup ISO 13485:2003 and have a medical device CE marked - I am in Australia. I have all the standards and have read them so can some one suggest the steps or what order you would tackle it from the beginning considering our product is about 90% complete. The product contains a user interface by means of a software driven touch screen and various other mechanical / electrical components.

My background is not Medical or Qa but rather Documentation/Training and procedure/ process design so I may ask a few more painfull questions.

Thanks Heaps......

Click to expand...

Hi DAMAS,

Welcome to The Cove.

I would find a Registrar and a Notified Body and become familiar with the MDD IEC 60601-1, IEC60601-1-4 as well as any other standards appropriate to your type of device. Your Notified Body may be able to help you with that. You will undoubtedly need to perform testing to show compliance with the various standards. Determine the class of device you manufacture according to MDD annex X. Review MDD Essential Requirements, Annex I. Determine which Annex (II,III,IV,V,VI,VII or VII) of the MDD you will use to gain entry. Develop a Technical File that shows compliance with the Essential Requirements. Concurrently you can work on registration to ISO 13485.

BTW, did I mention it can be a lot of work.

Hello Damas (Greetings from Austria to Australia)

DAMAS said:

Secondly I have been asked to Setup ISO 13485:2003 and have a medical device CE marked - I am in Australia. I have all the standards and have read them so can some one suggest the steps or what order you would tackle it from the beginning considering our product is about 90% complete. The product contains a user interface by means of a software driven touch screen and various other mechanical / electrical components.

Click to expand...

First question: Which Device du you produce?
Second q.: Do you want to sell it within the European Community? (Otherwise you do not need do have it CE-marked)

Next step is the classification of the device
and after that you would have to chose the type of conformity assessment.

If you tell us(me) more about your device, I can tell you more about your conformity requirements.

More Information

Hi Everyone,

Sounds like I only gave half the story in my first post so here is the second half.
Our Device is PhotoTherepy, using light to treat a variety of surface and subsurface skin conditions. No electrical connection to the patient. I have a copy of ISO 13485:2003, MDD (93-42) and ISO 14971. I have read them and can't say I totally understand every word however I get the idea. Yes Wrodnigg we do want to sell in the European Community. The company currently has a QA system in place (9001:2000) the system is used however not accredited. My department is a seperate identity to the other parts of the business that is using ISO 9001:2000 so can their forms/systems be referenced from the ISO 13485:2003 we are setting up or do we have to put inplace all procedures that the main company will be doing
for us as well. A lot of the components will be manufacturered and tested by other companies so what implications does this have on our systems?
Can someone give me an idea as to how long this entire process could take considering we don't have any thing in place at the moment. I am too scared in this post to ask about risk management - wills ave it for another one.

Thanks heaps

The manufacturer is responsible for CE-marking and all responsibilities within.
Manufacturers outside the EC need an "authorised representative" within the EC.

Your device is an active one, so it will be Class IIa or IIb. So you will need a Notified Body for your conformity procedure (I have posted the important milestones in an other thread).

The (responsible) manufacturer needs either a quality system or EC-verification (singe item, or statistical) certified by a Notified Body.

Sub-contractors may need a quality system, if they do important steps during manufacturing (with risk for the customer).

A good estimation to set up everything in place is difficult to give, approx. one year is realistic (faster, if you do not want to set up a quality system, but in this case each device must be tested by a notified body, and so this path is more expensive).

ISO13485 Guidance

I understand that there is a guidance document out for ISO13485:2003. Has anyone seen it and if so where can I get a copy??

Rick

rick melton said:

I understand that there is a guidance document out for ISO13485:2003. Has anyone seen it and if so where can I get a copy??

Rick

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The document you refer to is still a draft. You can follow this link.
https://www.aami.org/applications/search/results.cfm

ISO13485 Guidance

Thanks AL!!

Re: ISO13485 Guidance

rick melton said:

I understand that there is a guidance document out for ISO13485:2003. Has anyone seen it and if so where can I get a copy??

Rick

Click to expand...

Hi Rick,

You need to have a look at ISO 14969:2004