MD Compliance for Dummies - Relation between devices, directives and standards

[Jerome]

Hello Covers,

Since I don't know if this already exists, I'd like to make a form of flowchart to make life easier when it comes to the relation between devices, directives and standards. Since I'm fairly new and green to the subject I tend to lose the overview when I'm digging through al the standards.

The general idea is that everybody that thinks he or she can add or improve something about this flowchart can do so.

I made a quick sketch for medical devices, without the exceptions etc. (one has to start somewhere). I use a Visio drawing program but I can understand that a powerpoint based chart with buttons to other slides going deeper and deeper on specific standards etc. has more potential towards the future when this thing becomes bigger.

I hope some of you like to participate on this, build something yourselves (and share), or just correct me when I've got it all wrong.
Or show me that somebody already had this idea.

One of the reasons I'me trying to make this is I find new standards everyday having something to do with one or more of our products or parts of them. And I don't know anymore whats mandatory, wise to to or just nice to have.

Any comments, tips and critics are welcome on this quest for clarity.. :truce:

Jerome

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Being able to share information is what separates us from ..ermm.. the plants?

 

[Al Rosen]

Hello Covers,

Since I don't know if this already exists, I'd like to make a form of flowchart to make life easier when it comes to the relation between devices, directives and standards. Since I'm fairly new and green to the subject I tend to lose the overview when I'm digging through al the standards.

The general idea is that everybody that thinks he or she can add or improve something about this flowchart can do so.

I made a quick sketch for medical devices, without the exceptions etc. (one has to start somewhere). I use a Visio drawing program but I can understand that a powerpoint based chart with buttons to other slides going deeper and deeper on specific standards etc. has more potential towards the future when this thing becomes bigger.

I hope some of you like to participate on this, build something yourselves (and share), or just correct me when I've got it all wrong.
Or show me that somebody already had this idea.

One of the reasons I'me trying to make this is I find new standards everyday having something to do with one or more of our products or parts of them. And I don't know anymore whats mandatory, wise to to or just nice to have.

Any comments, tips and critics are welcome on this quest for clarity.. :truce:

Jerome

----------
Being able to share information is what separates us from ..ermm.. the plants?

I don't understand a few things.

1. Why does the chart indicate"ISO 13485 or ISO 9004"? Medical Devices manufacturers in the EU need ISO 13485 to meet the MDD and ISO 9004 is a guidance, not a system standard.
2. The IEC 60601 series of standards are for Electrical Medical Device "systems" not "parts". There are numerous standards for individual electrical "parts".
3. The same comment as 2 for Software "parts". The title of the IEC 60601-1-4 standard is: "General requirements for safety - Collateral standard: Programmable electrical medical systems". Would this be better identified as a branch of the Electrical "parts"(systems).

 

[Jerome]

Hi Al,

The chart (reed 'sketch') indicates ISO9001, but the 1 is crossing a line wich makes it look like a 4.
That about the systems not being parts is good to know, since I interperted it as it could be eigther.
I never said the chart was right, I just tried to post an idea.
Maybe I was to quick with throwing in a picture.
Still, I'll use your input to make it better and try to keep on doing so until I've got it all in place.
Thank you for your input.

Regards,
Jerome

 

[Al Rosen]

Hi Al,

The chart (reed 'sketch') indicates ISO9001, but the 1 is crossing a line wich makes it look like a 4.

ISO 9001 is still not appropriate for a Medical Device.