M
mr.mike
Hi Everyone,
First let me say, I REALLY appreciate the great help and advice I've got on these forums.... but being new to MD regulatory affairs, I realize I'm probably getting ahead of myself.
So to backtrack a bit, can someone out there offer guidance (or link to a good introductory document) for an unexperienced person such as myself as to the different standards, and how they interrelate?
Specifically, given that we'd like to keep our potential markets as large as possible, what are the documents that are critical to the MD industry?
From my own scouting about, I've come up with the following short-list (if you can correct/append/comment that'd be great!):
International: IEC 60601-1 (& its collateral and applicable vertical standards)
European-Union: MDD 93/42/EEC
United-States: FDA CFR 21
Australia: ARGMD (Australian Regulatory Guidelines for Medical Devices)
Canada: Health Canada SOR/98-282
Also, a continuing source of confusion for me is with the different bodies/groups issuing standards, how they differ, and where they apply.
Specifically, can someone clarify what's the difference between ISO, IEC, EN and UL?
Apologies for the randomness of this post, but it seems like I'm doing a lot of reading without a clear picture of what's-what.
Any guidance to get me a handle on all these different bodies/regions/standards etc. would be much appreciated!
As always, thank you kindly!
MM.
First let me say, I REALLY appreciate the great help and advice I've got on these forums.... but being new to MD regulatory affairs, I realize I'm probably getting ahead of myself.
So to backtrack a bit, can someone out there offer guidance (or link to a good introductory document) for an unexperienced person such as myself as to the different standards, and how they interrelate?
Specifically, given that we'd like to keep our potential markets as large as possible, what are the documents that are critical to the MD industry?
From my own scouting about, I've come up with the following short-list (if you can correct/append/comment that'd be great!):
International: IEC 60601-1 (& its collateral and applicable vertical standards)
European-Union: MDD 93/42/EEC
United-States: FDA CFR 21
Australia: ARGMD (Australian Regulatory Guidelines for Medical Devices)
Canada: Health Canada SOR/98-282
Also, a continuing source of confusion for me is with the different bodies/groups issuing standards, how they differ, and where they apply.
Specifically, can someone clarify what's the difference between ISO, IEC, EN and UL?
Apologies for the randomness of this post, but it seems like I'm doing a lot of reading without a clear picture of what's-what.
Any guidance to get me a handle on all these different bodies/regions/standards etc. would be much appreciated!
As always, thank you kindly!
MM.