Smith Associates, FDA Consultants

Smith Associates, FDA Consultants Consultants Specializing in Regulatory Affairs for FDA Compliance

Our Services
510(k) Submission (Pre-Market Notification)
513g Submissions for Classification Ruling
Pre-IDE Consulting
IDE (Investigational Device Exemption)
PMA/BLA (Pre-Market Approval)
Human Factor Study and Performance Testing
Drug Monograph Registration and Consulting
United States Agent/Official Correspondent Services

Quality System Compliance:
Quality System Part 820 (cGMP) Templates for s

mall and large companies
Quality System Implementation
Quality System Audits

Crisis Management:
483 Responses
Warning Letter Response
Recall Assistance

09/15/2021

**Looking for COPD and Asthma participants to participate in a Usability Study.***

Need 4 "pediatric - ages 5 - 21 years old) with asthma
Need 6 adults - ages 22+ with asthma or copd

Usability Study: Spirometer

Pay: $75.00 CASH
Time: 45 Minutes

What is it about? The usability of a Spirometer is the object of this study, which will ensure that the intended users can correctly and safely use the device with the included instructions for use.

What will you do? Assemble Spirometer, download app , read instructions for use and actual Spirometer use will be monitored by the study staff.

Message the page if interested!

09/10/2018

Respiratory Therapist Wanted for a usability study.
Pay: $100
Time: Approximately 30 minutes.
-
What is it about? The usability of a Speaking Valve is the object of this usability study, which will ensure that the intended users can correctly and safely use the device. The study will include professional users that are experienced in tracheostomy tube intubation. The actual use of the system with the assembly, pre-use check, installation, and removal of the Safety Speaking Valve (DRV) will be monitored by the study staff.

08/29/2018

WANTED: 10 Respiratory Therapist for a user study. This study will take approximately 20 minutes. Please message the page for details.

Welcome Pharma PhD
10/27/2017

Welcome Pharma PhD

Day one in the books. Had a visit from the ambassador to Dubai.
01/30/2017

Day one in the books. Had a visit from the ambassador to Dubai.

Smith Associates has arrived at Arab Health with Maryland State! Great looking booth MD. Looking forward to a great fist...
01/30/2017

Smith Associates has arrived at Arab Health with Maryland State! Great looking booth MD. Looking forward to a great fist day.

We will be hosting the User Performance Study in Hunt Valley, MD this week - Saturday, January 30th. Interested? Fill ou...
01/25/2016

We will be hosting the User Performance Study in Hunt Valley, MD this week - Saturday, January 30th. Interested? Fill out the survey at www.humanfactorstudy.com

Smith Associates FDA Consultants will be performing a User Performance Study on the Gold-Accu Blood Glucose Monitoring System manufactured by Sinocare Inc. This study requires 100 diabetic individuals to visit a lab in the Hunt Valley, MD area. This study will require approximately one hour of t…

11/21/2015

Thank you to all those who are participating in the User Performance Study today. We will be adding a more dates to our calendar. If you have not signed up for the study - please do so by visiting www.humanfactorstudy.com

Would you like to earn $100 this weekend? We need your help for a User Performance Study testing a glucose meter Saturda...
11/19/2015

Would you like to earn $100 this weekend? We need your help for a User Performance Study testing a glucose meter Saturday, November 21st. To be considered please complete the form at www.humanfactorstudy.com. (Study to take place in the Baltimore Metro area.)

Smith Associates FDA Consultants will be performing a User Performance Study on the Gold-Accu Blood Glucose Monitoring System manufactured by Sinocare Inc. This study requires 100 diabetic individuals to visit a lab in the Hunt Valley, MD area. This study will require approximately one hour of t…

National Diabetes Month.
11/04/2015

National Diabetes Month.

During American Diabetes Month this November, help us build the true picture of diabetes.

Address

P. O. Box 4341
Crofton, MD
21114

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