Technical Reports - Class 2 medical device design and manufacturing

M
#11
Yes, it help me to understand this better. Simcom Inc. or Corp. offers a set of books to help companies with compliance with 3 basic European Standards. The books are presented in a checklist format and contain data for recording results as required by standards. These documents design to take the engineer thru the standards and they are long,-60 to 80 pages. Manufacturers who design and test their own equipment need this as part of the Declaration of Conformance that you need for CE.

Big JOB!!!!!!!!!

Good luck, Mike
 
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T
#12
This is my first post.

From what I have read in this thread, it seems that you may want to refer to and follow the Medical Device Directive or MDD(COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices). If you are interested, I found a copy on-line at http://europa.eu.int - Link was: /eur-lex/en/lif/dat/1993/en_393L0042.html

It sounds as though you need to compile a technical file as described in the MDD. The major (not only) requirement is that you meet the essential requirements listed in the above document in Annex I.

Before you compile the technical file is in your best interest to determine your device's class according to the European system (class I, IIa, IIb or III) and then determine the conformity assessment path you want to take.

I hope this is helpful.

Just curious, who is your Notified Body?

Tom
 

barb butrym

Quite Involved in Discussions
#13
I believe the notified body is ITS, don't have the contract yet, so I am missing details....I am just getting prepared....as I know they are in a hurry.

thank you for the direction...am headed there now.
 
A

Andrew Johnston

#14
Barb,

a great source for CE marking and technical file guidance documents is the UK medical devices agency (The MDA is The UK's competant authority for CE marking medical devices, and are amongst other things, responsible for appointing the notified bodies)

http://www.medical-devices.gov.uk - Link Was: /reg-guid.htm

hope this helps,

Andrew.
 
M

M-Eritus

#15
Are you familiar with 510k submissions? Medical Device company seeks Regulatory Submissions Manager in the Bay Area...
Marguerite Bache
 
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