ISO 13485 Certification - Device Technical File in conjunction with QMS development

N

nbioe

#1
Is there advice for someone currently manufacturing equipment (which is already distributed internationally, but is not yet (may or may-never be) considered a medical device) and is looking to comply with CE guidelines by trying to develop a technical file in conjunction with the development of their QMS?
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: ISO 13485 Certification - device technical file

Is there advice for someone currently manufacturing equipment (which is already distributed internationally, but is not yet (may or may-never be) considered a medical device) and is looking to comply with CE guidelines by trying to develop a technical file in conjunction with the development of their QMS?
Hi nbioe - I'm a little confused... ISO13485 and CE marking to the MDD are related but different topics.

Are you looking to develop a TF to the requirements of the MDD, or looking to meet the 13485 design and development criteria with a design history file or th like?
 
N

nbioe

#3
Re: ISO 13485 Certification - device technical file

ScottK,
Yes, sorry for the confusion, I should have been clearer.
Because we sell internationally, we are trying to accommodate both. We are working toward ISO 13485 cert, however, my immediate need is a TF for MDD.
Having trouble with where to start TF for a product that is already in the field.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Re: ISO 13485 Certification - device technical file

ScottK,
Yes, sorry for the confusion, I should have been clearer.
Because we sell internationally, we are trying to accommodate both. We are working toward ISO 13485 cert, however, my immediate need is a TF for MDD.
Having trouble with where to start TF for a product that is already in the field.
Start like you just designed it. You'll need the same elements whether it's a new product or not. Plenty of companies sell a product in their home market then move into the EU.

Here's a pretty rough overview:
http://www.601help.com/Regulatory/technical_file.html

But if you have no one in your company who has done this before I would highly recomment hiring a a consultant to get you rolling and explain the process for your device.
 
M

MIREGMGR

#5
Re: ISO 13485 Certification - device technical file

Is there advice for someone currently manufacturing equipment (which is already distributed internationally, but is not yet (may or may-never be) considered a medical device)...
You probably should work through the appropriate definitions (noting that they differ slightly among USA, Canada, EU, others) to determine whether your product is or is not a regulated medical device. I'd think it unlikely that a Notified Body would be comfortable working with you on either an ISO 13485 certificate or (if your product is MDD Class IIa or higher) without an existing understanding of its device status. "May or may not be" isn't a viable status on an ongoing basis.

I gather from your location that you're in USA. If you're marketing in USA and exporting, but just developing a QMS, what is your US FDA status?
 
N

nbioe

#6
Re: ISO 13485 Certification - Device Technical File in conjunction with QMS developme

ScottK,
Thank you!!! That is exactly the start I needed. We do have a consultant lined up, but wanted to prepare as much as possible up front.

MIREGMGR,
Thank you kindly, but our "equipment" is more complex than I can discuss here. I am aware of international regs and their "appropriate" definitions. I stated correctly, that currently it is not classified as a medical device. FDA, EU, and Health Canada are all good with that as it stands. In the future, it is possible, that as the equipment changes, it may be considered a medical device. We believe in being prepared.
 
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