Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi -- my friend is developing a Class III medical imaging device and asked me to recommend a regulatory affairs consultant.

I am drawing a blank -- there probably aren't a lot of consultants with expertise in both PMA submissions and medical imaging as the few Class III imaging devices are generally submitted by large companies with their own inhouse RA departments.

If I had to pick either PMA experience or medical imaging, it seems to me that the medical imaging part is probably more important.

Any recommendations or advice?

Thank you.

Original Message:
Sent: 3/17/2021 2:26:00 AM
From: Anonymous Member
Subject: Consultant needed -- medical imaging

This message was posted by a user wishing to remain anonymous

Hi -- my friend is developing a Class III medical imaging device and asked me to recommend a regulatory affairs consultant.

I am drawing a blank -- there probably aren't a lot of consultants with expertise in both PMA submissions and medical imaging as the few Class III imaging devices are generally submitted by large companies with their own inhouse RA departments.

If I had to pick either PMA experience or medical imaging, it seems to me that the medical imaging part is probably more important.

Any recommendations or advice?

Thank you.

This message was posted by a user wishing to remain anonymous

There are several consultants in US that have experts in the team on PMA and imaging, some have ex-FDA employees. Me and my colleagues have good experiences with Msquared associates, https://www.msquaredassociates.com/. They are really helpfull for novel devices and start-ups.
Original Message:
Sent: 17-Mar-2021 02:26
From: Anonymous Member
Subject: Consultant needed -- medical imaging

This message was posted by a user wishing to remain anonymous

Hi -- my friend is developing a Class III medical imaging device and asked me to recommend a regulatory affairs consultant.

I am drawing a blank -- there probably aren't a lot of consultants with expertise in both PMA submissions and medical imaging as the few Class III imaging devices are generally submitted by large companies with their own inhouse RA departments.

If I had to pick either PMA experience or medical imaging, it seems to me that the medical imaging part is probably more important.

Any recommendations or advice?

Thank you.

This message was posted by a user wishing to remain anonymous

I would suggest NDA Partners, LLC.NDA Partners LLC

They have several capable consultants who have worked on Class III/PMA imaging devices and also combination product imaging device/drugs.
Original Message:
Sent: 17-Mar-2021 02:26
From: Anonymous Member
Subject: Consultant needed -- medical imaging

This message was posted by a user wishing to remain anonymous

Hi -- my friend is developing a Class III medical imaging device and asked me to recommend a regulatory affairs consultant.

I am drawing a blank -- there probably aren't a lot of consultants with expertise in both PMA submissions and medical imaging as the few Class III imaging devices are generally submitted by large companies with their own inhouse RA departments.

If I had to pick either PMA experience or medical imaging, it seems to me that the medical imaging part is probably more important.

Any recommendations or advice?

Thank you.

PM Me. I have contacts that worked at AGFA Film, FujiFilm, Kodak and several PACS companies.

------------------------------
Edward Panek
VP, QA/RA
Med Device

DOD/DARPA/Dept Veterans Affairs Design Controls in Research

Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 17-Mar-2021 02:26
From: Anonymous Member
Subject: Consultant needed -- medical imaging

This message was posted by a user wishing to remain anonymous

Hi -- my friend is developing a Class III medical imaging device and asked me to recommend a regulatory affairs consultant.

I am drawing a blank -- there probably aren't a lot of consultants with expertise in both PMA submissions and medical imaging as the few Class III imaging devices are generally submitted by large companies with their own inhouse RA departments.

If I had to pick either PMA experience or medical imaging, it seems to me that the medical imaging part is probably more important.

Any recommendations or advice?

Thank you.

Good news, most likely the device will be a Class II, as a general rule.  Though by your asking about PMA submissions, perhaps your friend has a device that is novel and without predicate, so perhaps Class III. I've been involved with diagnostic imaging for several years, both from the technology development and the regulatory side, and we celebrate when they intersect.  Feel free to reach out and I could share the battle scars and help answer the "regulatory" v "medical imaging" question.  Better news, as you are finding, there is a lot of talent and expertise in the forum.

------------------------------
Larry Lugo
Consultant
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 17-Mar-2021 02:26
From: Anonymous Member
Subject: Consultant needed -- medical imaging

This message was posted by a user wishing to remain anonymous

Hi -- my friend is developing a Class III medical imaging device and asked me to recommend a regulatory affairs consultant.

I am drawing a blank -- there probably aren't a lot of consultants with expertise in both PMA submissions and medical imaging as the few Class III imaging devices are generally submitted by large companies with their own inhouse RA departments.

If I had to pick either PMA experience or medical imaging, it seems to me that the medical imaging part is probably more important.

Any recommendations or advice?

Thank you.

This message was posted by a user wishing to remain anonymous

Thanks all for the pointers!  Ginger, in this case there are no tracers involved.  Larry, definitely a Class III device.

I will refer my friend to M Squared and NDA.  I have heard good things about these firms.  

I didn't realize there were so many imaging folks on this forum.  Good to learn that.  I may PM some of you to chat!

Original Message:
Sent: 17-Mar-2021 02:26
From: Anonymous Member
Subject: Consultant needed -- medical imaging

This message was posted by a user wishing to remain anonymous

Hi -- my friend is developing a Class III medical imaging device and asked me to recommend a regulatory affairs consultant.

I am drawing a blank -- there probably aren't a lot of consultants with expertise in both PMA submissions and medical imaging as the few Class III imaging devices are generally submitted by large companies with their own inhouse RA departments.

If I had to pick either PMA experience or medical imaging, it seems to me that the medical imaging part is probably more important.

Any recommendations or advice?

Thank you.

Hi there,

At G&L Scientific we have access to a huge pool of consultants with a vast variety of expertise. Please feel free to drop me an email and I can look at getting a proposal together with some resumes to have a look at.  kcraigs@gandlscientific.com

Kind regards,

Kallam

------------------------------
Kallam Craigs
Client Services Executive
Cambridge MA
United States
------------------------------

Original Message:
Sent: 05-Apr-2021 04:41
From: Anonymous Member
Subject: Consultant needed -- medical imaging

This message was posted by a user wishing to remain anonymous

Thanks all for the pointers!  Ginger, in this case there are no tracers involved.  Larry, definitely a Class III device.

I will refer my friend to M Squared and NDA.  I have heard good things about these firms.

I didn't realize there were so many imaging folks on this forum.  Good to learn that.  I may PM some of you to chat!

Original Message:
Sent: 17-Mar-2021 02:26
From: Anonymous Member
Subject: Consultant needed -- medical imaging

This message was posted by a user wishing to remain anonymous

Hi -- my friend is developing a Class III medical imaging device and asked me to recommend a regulatory affairs consultant.

I am drawing a blank -- there probably aren't a lot of consultants with expertise in both PMA submissions and medical imaging as the few Class III imaging devices are generally submitted by large companies with their own inhouse RA departments.

If I had to pick either PMA experience or medical imaging, it seems to me that the medical imaging part is probably more important.

Any recommendations or advice?

Thank you.

Hello: I have PMA, 510k, and pre-submission experience with imaging devices. Both PMA submission or medical imaging experience are important especially if the device contains software which is where advanced imaging is going. Good luck!

------------------------------
John DeLucia
Consultant
------------------------------

Original Message:
Sent: 17-Mar-2021 02:26
From: Anonymous Member
Subject: Consultant needed -- medical imaging

This message was posted by a user wishing to remain anonymous

Hi -- my friend is developing a Class III medical imaging device and asked me to recommend a regulatory affairs consultant.

I am drawing a blank -- there probably aren't a lot of consultants with expertise in both PMA submissions and medical imaging as the few Class III imaging devices are generally submitted by large companies with their own inhouse RA departments.

If I had to pick either PMA experience or medical imaging, it seems to me that the medical imaging part is probably more important.

Any recommendations or advice?

Thank you.