847.549.0390  |    www.protocollink.com  |  Vernon Hills, IL
No, you didn't miss us last month!  The Protocol Link Newsletter will now be brought to your inboxes on a bi-monthly basis, providing you with the latest industry news and commentary.
A quick reminder to our Medical Device followers
FDA's eMDR Final Rule date is August 14, 2015 . Contact us if you have questions or need last minute MDR transition support!
Notable Links
Data Integrity - Documents and Records
Daniel J. Hoch, Ph.D.
Vice President, Protocol Link
"Data Integrity" is an item which has garnered FDA and industry attention over the past year.  This buzz-word first received notoriety with respect to the inspection of laboratories based on their implementation of computerized systems having the ability to generate records with no apparent means of traceability.  In recent years, however, concerns about falsification of records due to the lack of ability to verify data entries has expanded to all areas of FDA regulated operations.

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openFDA: Open-source APIs for FDA Drug, Device, and Food Data

Scott Buckely

Project Manager, Protocol Link

 

In case you missed it, the FDA launched openFDA in Beta mode in June of 2014, and it seems to be very well received.  The public portal was developed by the FDA to create open access to public data and allow for that data to be easily used by developers in applications.  The site was designed to be an open system and was built using open source software and standards.

 

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The Evolving Regulatory Landscape for Mobile Apps

Christine Shumard-Sauer

Director, Protocol Link 

 

In the digital age, consumers are increasingly using technology such as mobile apps on smartphones and wearable sensors to monitor health. This area of healthcare, called digital medicine, is rapidly expanding with technologies that will revolutionize the way we identify, diagnose, monitor and treat health conditions.


 

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A Word from Our Staff
" Protocol Link has an extensive talent acquisition process to identify the right consulting candidate(s) for each project where specific supplemental skill sets are required. Consultants are interviewed multiple times by company SMEs before Protocol Link assigns the right talented consultant(s) to the project.  Additionally, each project has company SME and senior leadership support at all stages of the project!  This approach brings a comfort and confidence to our clients that the project will be completed the right way, every time.  This is evident by the repeat opportunities Protocol Link receives from our clients."
Ankit Patel
Senior Manager, Process and Technology
Protocol Link, Inc.
847.549.0390  | www.protocollink.com  |   Vernon Hills, IL
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