Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

We have BSI and there responsiveness is terrible. It has been for the 3 years I've been in my current role. Intertek ISO auditing arm was great, but we used their Amtac NB service, which is now obsolete. Several consultants and former NB employees have said that all NBs right now are struggling and none of them responding in a timely manner. One former NB employee said that big NBs have a parking lot where they move smaller customers, even if work on an audit has already started, while they focus on their bigger customers. Don't know if that's their actual business practice, but it sure feels like it!  You might find that while working with the sales person at an NB, you get lots of timely communication to win your business, but that drops to unresponsive when you're actually on board. We looked into changing NBs and one sales person said they were already overloaded but could probably find a way to squeeze us in. We didn't go that route.
Good luck,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

Hi Jackie,

We're very sorry to hear that you're having issues with BSI's responsiveness. Please reach out to Bill Enos, Sr. Commercial Operations Director Regulatory Services, directly at bill.enos@bsigroup.com to discuss what the issues are and how they can be resolved.

Thanks,
Derek

------------------------------
Derek Legendre
Herndon VA
United States
------------------------------

Original Message:
Sent: 12-Jun-2021 11:13
From: Jackie Jaskula
Subject: NB responsiveness - opinions?

We have BSI and there responsiveness is terrible. It has been for the 3 years I've been in my current role. Intertek ISO auditing arm was great, but we used their Amtac NB service, which is now obsolete. Several consultants and former NB employees have said that all NBs right now are struggling and none of them responding in a timely manner. One former NB employee said that big NBs have a parking lot where they move smaller customers, even if work on an audit has already started, while they focus on their bigger customers. Don't know if that's their actual business practice, but it sure feels like it!  You might find that while working with the sales person at an NB, you get lots of timely communication to win your business, but that drops to unresponsive when you're actually on board. We looked into changing NBs and one sales person said they were already overloaded but could probably find a way to squeeze us in. We didn't go that route.
Good luck,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

Thanks, Derek. We'll do that!
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 14-Jun-2021 08:39
From: Derek Legendre
Subject: NB responsiveness - opinions?

Hi Jackie,

We're very sorry to hear that you're having issues with BSI's responsiveness. Please reach out to Bill Enos, Sr. Commercial Operations Director Regulatory Services, directly at bill.enos@bsigroup.com to discuss what the issues are and how they can be resolved.

Thanks,
Derek

------------------------------
Derek Legendre
Herndon VA
United States

Original Message:
Sent: 12-Jun-2021 11:13
From: Jackie Jaskula
Subject: NB responsiveness - opinions?

We have BSI and there responsiveness is terrible. It has been for the 3 years I've been in my current role. Intertek ISO auditing arm was great, but we used their Amtac NB service, which is now obsolete. Several consultants and former NB employees have said that all NBs right now are struggling and none of them responding in a timely manner. One former NB employee said that big NBs have a parking lot where they move smaller customers, even if work on an audit has already started, while they focus on their bigger customers. Don't know if that's their actual business practice, but it sure feels like it!  You might find that while working with the sales person at an NB, you get lots of timely communication to win your business, but that drops to unresponsive when you're actually on board. We looked into changing NBs and one sales person said they were already overloaded but could probably find a way to squeeze us in. We didn't go that route.
Good luck,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

Hi Jackie,

We have also found BSI's responsiveness to be slow. I agree, after we submitted the application, sales responded pretty quickly. Since then, the responsiveness has dropped (particularly since January of this year). We are a small startup (<100 employees).

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 12-Jun-2021 11:13
From: Jackie Jaskula
Subject: NB responsiveness - opinions?

We have BSI and there responsiveness is terrible. It has been for the 3 years I've been in my current role. Intertek ISO auditing arm was great, but we used their Amtac NB service, which is now obsolete. Several consultants and former NB employees have said that all NBs right now are struggling and none of them responding in a timely manner. One former NB employee said that big NBs have a parking lot where they move smaller customers, even if work on an audit has already started, while they focus on their bigger customers. Don't know if that's their actual business practice, but it sure feels like it!  You might find that while working with the sales person at an NB, you get lots of timely communication to win your business, but that drops to unresponsive when you're actually on board. We looked into changing NBs and one sales person said they were already overloaded but could probably find a way to squeeze us in. We didn't go that route.
Good luck,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

Hiral,
There was a response from Derek Legendre who suggested reaching reach to Bill Enos, Sr. Commercial Operations Director Regulatory Services, directly at bill.enos@bsigroup.com. We're planning to do that. You might want to consider as well.
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 14-Jun-2021 13:51
From: Hiral Dutia
Subject: NB responsiveness - opinions?

Hi Jackie,

We have also found BSI's responsiveness to be slow. I agree, after we submitted the application, sales responded pretty quickly. Since then, the responsiveness has dropped (particularly since January of this year). We are a small startup (<100 employees).

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 12-Jun-2021 11:13
From: Jackie Jaskula
Subject: NB responsiveness - opinions?

We have BSI and there responsiveness is terrible. It has been for the 3 years I've been in my current role. Intertek ISO auditing arm was great, but we used their Amtac NB service, which is now obsolete. Several consultants and former NB employees have said that all NBs right now are struggling and none of them responding in a timely manner. One former NB employee said that big NBs have a parking lot where they move smaller customers, even if work on an audit has already started, while they focus on their bigger customers. Don't know if that's their actual business practice, but it sure feels like it!  You might find that while working with the sales person at an NB, you get lots of timely communication to win your business, but that drops to unresponsive when you're actually on board. We looked into changing NBs and one sales person said they were already overloaded but could probably find a way to squeeze us in. We didn't go that route.
Good luck,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

Good morning,

During this crazy period, I found very good responsiveness in Tuv Sud and SGS.

We are 1000 employees company.

Beast regards
K

---------------------------------
Katarzyna Chrusciel
Engineer

Italy
---------------------------------



Original Message:
Sent: 11-Jun-2021
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

I have had really great responsiveness from TUV SUD and SGS as well.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 12-Jun-2021 13:18
From: Katarzyna Chrusciel
Subject: NB responsiveness - opinions?

Good morning,

During this crazy period, I found very good responsiveness in Tuv Sud and SGS.

We are 1000 employees company.

Beast regards
K

---------------------------------
Katarzyna Chrusciel
Engineer

Italy

Original Message:
Sent: 11-Jun-2021
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

This message was posted by a user wishing to remain anonymous

We are a small company. BSI's responsiveness is horrible/
Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

I just received notification the person handling our most recent submission left our NB after only 9 months. I suspect it's quite chaotic as some NB right now and the workload is immense. Qualified employees are hard to come by right now for this type of work so I don't expect it to change much soon.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

This message was posted by a user wishing to remain anonymous

Thanks everyone for your responses! It was a huge help.
Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

We have found BSI to generally be responsive. There have been delays in reviews and they have communicated when those are expected to be completed. It is true that MDR has thrown everyone a curve ball.

------------------------------
Vidya
USA
------------------------------

Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!

I have heard from some clients that one NB is great and responsive and the same NB is totally unresponsive. So, it really depends on the project, the file manager, and the client, the NB backlog, and sometimes the size of the company as noted in some of the posts.  I think many companies will have different experiences with the same NB's.  I think if one company has a great experience with a certain contact at an NB I would ask for that contact info and pass it on would be really helpful for others as that will be the "golden ticket" to make life easier in the process.  Knowing the right people at the NBs certainly does make the process easier, especially since I have worked at 3 different ones over 27 years (with breaks in between).

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 11-Jun-2021 13:18
From: Anonymous Member
Subject: NB responsiveness - opinions?

This message was posted by a user wishing to remain anonymous

Hello all,

We are planning on transitioning away from our current NB and 13485 auditor while we transition to MDR. This is for a multitude of reasons, not the least of which is general unresponsiveness. While we understand that MDR has placed a huge burden on the NBs, this has been ongoing for years.

Have you found some NBs more responsive and helpful than others? Particularly, have you had good success with BSI, Intertek, or TUV SUD?

I apologize if this is not allowed.

Thank you!