The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
Forum Username

Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Donate and $ Contributor Forum Access

Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 30th September 2009, 05:29 AM
mwa mwa is offline
Involved in Discussions

 
 
Posts: 30
Please Help! Documentation of OEM Device - Technical File for a Class IIa Medical Device

All ,


Can anyone give me some advice regarding this .

I am preparing a Technical file for a class II a medical device in EU . We are manufacturing this device in a contract manufacturing facility . So this device is for us a OEM device . This product is not registered by the contract manufacturer. we are going to register it for the first time.

My question , Apart from normal content of technical file , what extra document should i need to have in our technical file regarding this (that the device is manufactured by another medical device facility)?

Thanks for your help in advance

Sponsored Links
  #2  
Old 30th September 2009, 07:41 AM
chris1price chris1price is offline
Courtesy Access

 
 
Posts: 174
Re: Documentation of OEM Device

Hi

I would include a flowchart for the manufacturing process and a descrption of the inspection procedures at the sub-contractor and your receiving inspection process.

You may also want to include a copy of your quality plan, agreement or contract with the sub-contractor.

Chris
Sponsored Links

  #3  
Old 30th September 2009, 09:57 AM
MIREGMGR MIREGMGR is offline
Appreciated Information Resource

 
 
Posts: 3,355
Re: Documentation of OEM Device - Technical File for a Class IIa Medical Device

You should include more-detailed discussions of any critical material specifications, and any validated processes and critical functional verifications during manufacturing; how the contract manufacturer controls them; and how you control the contract manufacturer.
  #4  
Old 30th September 2009, 10:53 AM
mwa mwa is offline
Involved in Discussions

 
 
Posts: 30
Re: Documentation of OEM Device - Technical File for a Class IIa Medical Device

We haven't performed any validation over there. Is there a special template for the agreement between OEM and PLM ?

Last edited by Stijloor; 30th September 2009 at 02:13 PM. Reason: Typo's.
  #5  
Old 30th September 2009, 05:25 PM
rthompson rthompson is offline
Involved in Discussions

 
 
Posts: 20
Re: Documentation of OEM Device - Technical File for a Class IIa Medical Device

If the contract manufacturing facility is ISO certified, I would definitely include that as well under a "Supplier Quality" section of the technical file.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Medical Device Technical Files (Class IIa & IIb) – Design Development Documentation SteveK EU Medical Device Regulations 7 2nd January 2014 04:50 AM
Class II Medical Device Technical File Checklist Christopher01 CE Marking (Conformité Européene) / CB Scheme 20 13th December 2013 04:02 AM
How do I create a Technical File for a Class IIa Medical Device sim.s EU Medical Device Regulations 4 30th July 2010 10:20 AM
Medical Device Class I and Class IIa Differences? Inhalator googgic ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 9 26th November 2007 06:27 PM
Class IIa Medical Device and Subcontracting questions jalocas ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 3 8th June 2007 07:52 AM



The time now is 04:11 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".