J. E. Lincoln and Associates LLC

 

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Regulatory Affairs - Quality Systems

Medical Devices - Pharmaceuticals 

- Combination Products

- Dietary Supplements

- Validations

- Product Risk Management

Consulting 

- over 36 years cGMP experience

"Business Success From Regulatory Compliance"™


 

Helping companies to understand

and meet regulatory requirements --

Improved cGMP compliance through...

 

                                                           "Completed Staff Work"(TM)

 

 


Phone 435-840-0252  (use Skype only for prearranged calls)               

E-mail   jel@jelincoln.com

www.jelincoln.com

 

 

TOP 10 FAQ  | ABOUT US  | A TYPICAL PROJECT  | WHY HIRE US?  |  CLIENTS  TESTIMONIALS  |  US FDA QS REG  |  SOFTWARE V&V  |  SOPS/QM 

 NEW PROJECTS  |  PRODUCTS  |  DISCLAIMER  |  ETHICS         

 GUARANTEED CONSULTING 


 

IMPORTANT  RECENT  NEWS  LINKS:       What's Changed With ISO 13485:2016?"(from Parxiom);

And:        Final Guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device , released by U.S. FDA October 25, 2017; 

And:        
Final Guidance on Deciding When to Submit a 510(k) for a Software Change to an Existing Device, released by U.S. FDA October 25, 2017. 

And:       
Final Guidance on Cybersecurity in Networked Medical Devices, released by U.S. FDA December 28, 2016; 


JOHN'S  FEATURED  WEBINAR: 

JOHN'S  IVT  ARTICLES: John's JVT / GXP Articles

Visit John's blog on CGMP ISSUES

See John's Profile on LINKEDIN


Site created/updated by John E. Lincoln.

Copyright 1996 - 2018 J. E. Lincoln and Associates LLC.      All rights reserved

                            Site last updated on 08/23/2018.