Posted On: 08/27/2013 3:45:33 AM
Post# of 1609
Another peace of DD of mine that proofs that Emergo truly got hired by Sndy. This is Renes reply to my inquiry
Dear Dr. .........
Thank you for linking us with Solon Endoscopy. I am sure you will appreciate that we do not disclose information about our clients once we have contracts with them in place , but I am happy to comment on the public press release which should cover most of your questions.
They are anticipating the have CE Marking and Canadian approvals by the end of the year which will allow them to place the device on the European and Canadian markets. Emergo Europe act as the European Authorized Representative (EAR), which a regulatory role and not a commercial role! The European law for medical devices require for manufacturers that do not have a place of business in Europe to select a point of contact (EAR) for European inspection authorities in the event there of vigilance (adverse events) related issues. The EAR will also be responsible for the device notification of the device where applicable. As the EAR we are not involved in distribution and sales of the device. What Canada concerns, there is no such requirement as the one that exists in Europe where you need to have a local representative irrespective whether the manufacturer has a place of business in Canada or not.
Hope this clarifies most of your questions. I cannot comment on what I think of the company or their devices.
Kind regards,
Rene
Rene van de Zande
EMERGO GROUP | President & CEO
USA office: 816 Congress Avenue | Suite 1400 | Austin, Texas 78701
Office: +1.512.327.9997
Online: www.EmergoGroup.com
How are we doing? Give us feedback.
Seems like we are well on our ways!
Dear Dr. .........
Thank you for linking us with Solon Endoscopy. I am sure you will appreciate that we do not disclose information about our clients once we have contracts with them in place , but I am happy to comment on the public press release which should cover most of your questions.
They are anticipating the have CE Marking and Canadian approvals by the end of the year which will allow them to place the device on the European and Canadian markets. Emergo Europe act as the European Authorized Representative (EAR), which a regulatory role and not a commercial role! The European law for medical devices require for manufacturers that do not have a place of business in Europe to select a point of contact (EAR) for European inspection authorities in the event there of vigilance (adverse events) related issues. The EAR will also be responsible for the device notification of the device where applicable. As the EAR we are not involved in distribution and sales of the device. What Canada concerns, there is no such requirement as the one that exists in Europe where you need to have a local representative irrespective whether the manufacturer has a place of business in Canada or not.
Hope this clarifies most of your questions. I cannot comment on what I think of the company or their devices.
Kind regards,
Rene
Rene van de Zande
EMERGO GROUP | President & CEO
USA office: 816 Congress Avenue | Suite 1400 | Austin, Texas 78701
Office: +1.512.327.9997
Online: www.EmergoGroup.com
How are we doing? Give us feedback.
Seems like we are well on our ways!
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