Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I am seeking a consultant who has both toxicology and regulatory expertise to 1) support discussions with the FDA on bio-compatibility justifications with a pending submission, 2) support new resin selection and 3) for planning new submissions with both the FDA and CE. We are a low risk device with relatively benign materials - however we are seeking someone with a specific focus and experience. 

If you are interested, please reply with your contact information and I can reach out. 

Cheers!

Hi,
I'd be interested in helping. Please feel free to message me and we can discuss more details.

Best,
Mike

------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States
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Original Message:
Sent: 08-Feb-2018 18:35
From: Anonymous Member
Subject: Seeking consultant for questions related to biocompatibility

This message was posted by a user wishing to remain anonymous

I am seeking a consultant who has both toxicology and regulatory expertise to 1) support discussions with the FDA on bio-compatibility justifications with a pending submission, 2) support new resin selection and 3) for planning new submissions with both the FDA and CE. We are a low risk device with relatively benign materials - however we are seeking someone with a specific focus and experience.

If you are interested, please reply with your contact information and I can reach out.

Cheers!

Original Message------

This message was posted by a user wishing to remain anonymous

I am seeking a consultant who has both toxicology and regulatory expertise to 1) support discussions with the FDA on bio-compatibility justifications with a pending submission, 2) support new resin selection and 3) for planning new submissions with both the FDA and CE. We are a low risk device with relatively benign materials - however we are seeking someone with a specific focus and experience. 

If you are interested, please reply with your contact information and I can reach out. 

Cheers!

​Hey Anonymous,

We would be more than happy to help! Our team of certified toxicologists (in USA, EU and China) deals on an every day basis with the "specific" requirements from FDA, notified bodies and other regulatory agencies in terms of biocompatibility. They are involved in ISO 10993 standards commitees and are familiar with FDA presubmissions (inclduding the strategic planning) as well as expert panel reviews. 

If you feel this kind of expertise is what you were searching for please contact me.
Warm regards,
Isabelle

ilang@knoell.com

------------------------------
Isabelle Lang-Zwosta MD
Dr. Knoell Consult GmbH
Berlin
Germany
------------------------------

Original Message:
Sent: 08-Feb-2018 18:35
From: Anonymous Member
Subject: Seeking consultant for questions related to biocompatibility

This message was posted by a user wishing to remain anonymous

I am seeking a consultant who has both toxicology and regulatory expertise to 1) support discussions with the FDA on bio-compatibility justifications with a pending submission, 2) support new resin selection and 3) for planning new submissions with both the FDA and CE. We are a low risk device with relatively benign materials - however we are seeking someone with a specific focus and experience.

If you are interested, please reply with your contact information and I can reach out.

Cheers!

I sat on the AAMI/ISO Biocompatibility working groups for years. I'd be happy to help. Or- I know a number of really experienced toxicologists. Please message me.

Cheers,
Lisa

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Lisa Olson
Minneapolis MN
United States
------------------------------

Original Message:
Sent: 08-Feb-2018 18:35
From: Anonymous Member
Subject: Seeking consultant for questions related to biocompatibility

This message was posted by a user wishing to remain anonymous

I am seeking a consultant who has both toxicology and regulatory expertise to 1) support discussions with the FDA on bio-compatibility justifications with a pending submission, 2) support new resin selection and 3) for planning new submissions with both the FDA and CE. We are a low risk device with relatively benign materials - however we are seeking someone with a specific focus and experience.

If you are interested, please reply with your contact information and I can reach out.

Cheers!

We are a small medical device company that makes low risk disposables.  We outsource all biocomp/chemical decision making, report writing, coordination of testing, responses to FDA 510K) questions, etc. to a very talented consultant that specializes in  toxicology and biocomp.

If you are interested in his contact information, please reach out to me.

Thanks!

------------------------------
Melinda Smith MS, RAC
VP, Quality and Regulatory Affairs
Woodstock GA
United States
------------------------------

Original Message:
Sent: 08-Feb-2018 18:35
From: Anonymous Member
Subject: Seeking consultant for questions related to biocompatibility

This message was posted by a user wishing to remain anonymous

I am seeking a consultant who has both toxicology and regulatory expertise to 1) support discussions with the FDA on bio-compatibility justifications with a pending submission, 2) support new resin selection and 3) for planning new submissions with both the FDA and CE. We are a low risk device with relatively benign materials - however we are seeking someone with a specific focus and experience.

If you are interested, please reply with your contact information and I can reach out.

Cheers!

Original Message------

This message was posted by a user wishing to remain anonymous

I am seeking a consultant who has both toxicology and regulatory expertise to 1) support discussions with the FDA on bio-compatibility justifications with a pending submission, 2) support new resin selection and 3) for planning new submissions with both the FDA and CE. We are a low risk device with relatively benign materials - however we are seeking someone with a specific focus and experience. 

If you are interested, please reply with your contact information and I can reach out. 

Cheers!