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Identifying gaps over ISO 13485 to be compliant to MDD 93/42/EEC requirements

SGquality

Quite Involved in Discussions
#1
We have a location certified to ISO 13485 and would like to find gaps over 93/42/EEC requirements - does any one have ready reference.

Pls help :thanks:
 
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Ajit Basrur

Staff member
Admin
#2
Re: Identifying gaps over ISO 13485 to be compliant to EEC 93/42/EEC requirements

Thanks to Sreenu927 ... he had posted it earlier. I had earlier downloaded it in my computer and have attached. Will post the link if I find it.

Thanks to sreenu 927 again :)
 

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joemar

Involved In Discussions
#3
Re: Identifying gaps over ISO 13485 to be compliant to EEC 93/42/EEC requirements

Sorry to revive an old thread, but Im confused by how this matrix works. Because the matrix is based on 13485, the matrix shows areas of 13485 and how they are (or are not) addressed in the MDD, but it doesnt really show the opposite. Am I correct?

Does someone have a matrix that is based on 93/42/EEC? Id really like to see areas of 93/42/EEC that are not covered by 13485.

Am I just misreading this matrix? I assume this is available somewhere, right?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Identifying gaps over ISO 13485 to be compliant to EEC 93/42/EEC requirements

Hi,

In terms of QMS, there's nothing in the MDD that is not covered by ISO 13485. ISO 13485 compliance provides presumption of conformity with all MDD QMS requirements.

On the other hand, there are many requirements in MDD that are not covered by ISO 13485, becuase they are not QMS-specific. I'm not aware of a matrix showing that, but then I don't really rely on templates when implementing the MDD. I believe that the best way is to read the MDD itself on each and every implementation. I don't believe in canned thinking, though I understand why folks like it.

Cheers,
Ronen.
 

joemar

Involved In Discussions
#5
Re: Identifying gaps over ISO 13485 to be compliant to EEC 93/42/EEC requirements

while you are right, and I dont have any problem reviewing for gaps on my own (that's what Im doing), it is nice to have something to compare to. I am not that familiar with the MDD, and I can foresee myself making a mistake (even after reviewing it with diligence). So it would be nice to be able to cross check.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Identifying gaps over ISO 13485 to be compliant to EEC 93/42/EEC requirements

while you are right, and I dont have any problem reviewing for gaps on my own (that's what Im doing), it is nice to have something to compare to. I am not that familiar with the MDD, and I can foresee myself making a mistake (even after reviewing it with diligence). So it would be nice to be able to cross check.
Be careful. If you really want to cross check, the reference should take account of your specifics, as the MDD has a lot of conditional clauses. If you look at something generic it could either miss out on some concessions you may benefit, or be almost as burdensome as reading the MDD itself.

If you're looking for someone experienced to review your output please feel free to send me a PM.

Cheers,
Ronen.
 
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