Regulatory Open Forum

Hi,

I refer to a previous discussion on this group for this topic.

Dan had commented

"In the warranty period, the report is a valid compliant and needs investigation; there

are a number of Warning Letters to that effect. In the expected life period (after

warranty), it is probably a valid complaint and may or may not require an investigation."

Needed some clarification around this. After the warranty period but during the expected(service)life , what could be the rationale for not investigating a complaint ? When there is no requirement of  investigating complaints after the expected life , can this expected life be the service life ?

Thanks & Regards,

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

Hi,

I refer to a previous discussion on this group for this topic.

Dan had commented

"In the warranty period, the report is a valid compliant and needs investigation; there

are a number of Warning Letters to that effect. In the expected life period (after

warranty), it is probably a valid complaint and may or may not require an investigation."

Needed some clarification around this. After the warranty period but during the expected(service)life , what could be the rationale for not investigating a complaint ? When there is no requirement of  investigating complaints after the expected life , can this expected life be the service life ?

Thanks & Regards,

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

Hi,

I refer to a previous discussion on this group for this topic.

Dan had commented

"In the warranty period, the report is a valid compliant and needs investigation; there

are a number of Warning Letters to that effect. In the expected life period (after

warranty), it is probably a valid complaint and may or may not require an investigation."

Needed some clarification around this. After the warranty period but during the expected(service)life , what could be the rationale for not investigating a complaint ? When there is no requirement of  investigating complaints after the expected life , can this expected life be the service life ?

Thanks & Regards,

Rashmi Pillay
Regulatory Affairs Associate

Ellex 

3-4 Second Avenue

Mawson Lakes SA, 5095

T + 61 8 7074 8105
E  rpillay@ellex.com

W ellex.com

.............................................................................
 
One Powerful Vision.

Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document.