Elsmar Cove Quality DiscussionsAcquired Medical Devices - Company A buys the entire rightsThe Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
Acquired Medical Devices - Company A buys the entire rights
UL - Underwriters Laboratories - Health Sciences
Acquired Medical Devices - Company A buys the entire rights
Acquired Medical Devices - Company A buys the entire rights
Acquired Medical Devices - Company A buys the entire rights
Acquired Medical Devices - Company A buys the entire rights
Acquired Medical Devices - Company A buys the entire rights
Acquired Medical Devices - Company A buys the entire rights
Acquired Medical Devices - Company A buys the entire rights
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Acquired Medical Devices - Company A buys the entire rights


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
class i medical device, labeling requirements, medical devices
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 14th February 2018, 08:16 AM
JoCam's Avatar
JoCam

 
 
Total Posts: 206
Please Help! Acquired Medical Devices - Company A buys the entire rights

Hi All,

If Company A buys the entire rights (design, trade name, technical file, manufacturing etc.) of a class I medical device from Company B, does Company A need to re-label any historical stock of the product they acquire during the purchase with their name and address before being able to sell it?

Obviously Company A will need to ensure that any of the product they manufacture from their manufacturing facility going forwards will need to carry their address, and that a new Technical File, essential requirements checklist, Declaration of Conformity etc. will need to be compiled. However, in the meantime, what happens to the existing stock? Can it still carry Company B's name and address?

Jo

Sponsored Links
  Post Number #2  
Old 14th February 2018, 09:46 AM
chris1price

 
 
Total Posts: 218
Re: Acquired Medical Devices - Company A buys the entire rights

When I went through a similar experience, we made sure that customers could use the contact details on the old stock, (eg email, web address, phone numbers and physical address) and that the contact details all forwarded to the new company. We also repeatedly verified that the links were still working.
Thank You to chris1price for your informative Post and/or Attachment!
  Post Number #3  
Old 19th February 2018, 06:33 PM
QAengineer13

 
 
Total Posts: 107
Re: Acquired Medical Devices - Company A buys the entire rights

Quote:
In Reply to Parent Post by chris1price View Post

When I went through a similar experience, we made sure that customers could use the contact details on the old stock, (eg email, web address, phone numbers and physical address) and that the contact details all forwarded to the new company. We also repeatedly verified that the links were still working.
Thanks Chris for sharing your experience with us, I have another hypothetical situation where in say after you acquired the company with no doing lot of due diligence and then later it came to limelight that the previous design control documents had gaps say for instance in V&V and stuff, in that situation what would be a good approach to handle this case?
  Post Number #4  
Old 19th February 2018, 09:12 PM
pkost

 
 
Total Posts: 809
Re: Acquired Medical Devices - Company A buys the entire rights

It depends on what part of the V&V activities had been missed, is there any benefit in plugging the gap from a risk and safety perspective.

For example, if you didn't verify that the final design complied with customer requirements, then I would say risk is small. Write a short justification to say that the customer is now happily buying the product!

If however you forgot to validate the sterile barrier, then you urgently need to fix that and do the studies necessary to demonstrate that the product is sterile
Thanks to pkost for your informative Post and/or Attachment!
  Post Number #5  
Old 20th February 2018, 12:26 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,294
Re: Acquired Medical Devices - Company A buys the entire rights

Quote:
In Reply to Parent Post by JoCam View Post

Hi All,

If Company A buys the entire rights (design, trade name, technical file, manufacturing etc.) of a class I medical device from Company B, does Company A need to re-label any historical stock of the product they acquire during the purchase with their name and address before being able to sell it?

Obviously Company A will need to ensure that any of the product they manufacture from their manufacturing facility going forwards will need to carry their address, and that a new Technical File, essential requirements checklist, Declaration of Conformity etc. will need to be compiled. However, in the meantime, what happens to the existing stock? Can it still carry Company B's name and address?

Jo
During the complete process of buyout, a future (reasonable) date can be set for the regulatory, and communicated to the market. Company A and B together can agree upon how the regulatory transfer will be managed and completed.
Thank You to somashekar for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

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
Emoticons 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
Covering an acquired company in our ISO 13485 certification SGquality Registrars (Certification Bodies) and Registration 1 14th November 2017 08:28 PM
Labeling Requirements for Acquired Medical Device Inventory SylvieS Other US Medical Device Regulations 2 28th August 2017 09:18 PM
Merging Two Quality Management Systems when a Company is Acquired melissa87 Misc. Quality Assurance and Business Systems Related Topics 8 18th April 2014 12:00 PM
What happens to your ISO 9001 registration if you are acquired by a Company Without badbozz79 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2 28th January 2014 01:18 PM
Organization's Rights vs. Customer's Rights - Product Return vs. Replacement Ka Pilo Customer Complaints 13 8th February 2012 01:39 AM



The time now is 06:29 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"