Electronic Submission Gateway Work Instruction (WI-003)

Instructions on how to create an electronic submission gateway (ESG) for electronic submissions of a medical device report (MDR) to the FDA.

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Electronic submission gateway work instruction is available for $199.00:

ESG Work Instruction Electronic Submission Gateway Work Instruction (WI 003)
WI-003 Electronic Submission Gateway Work Instruction

This work instruction provides detailed instructions for creating an electronic submission gateway (ESG) for submission of a Medical Device Report (MDR), 510(k), and other types of electronic submissions to the US FDA or Health Canada.

Price: $199.00

The “Electronic Submission Gateway Work Instruction (WI-003)” is available for $199. If you would like a quotation for help with preparing a Medical Device Report (MDR) in accordance with 21 CFR 803, or another type of electronic submission for the US FDA or Health Canada, please use our calendly app to schedule a call with a member of our consulting team.

Important note regarding the delivery of the electronic submission gateway work instruction

This Electronic Submission Gateway Work Instruction (WI-003) will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. The email may be in your spam folder.

Additional resources to prepare for complaint handling and adverse event reporting

In addition to our Electronic Submission Gateway Work Instruction, you may also be interested in the following resources related to complaint handling and adverse event reporting:

About the Author

20190531 005146 150x150 Electronic Submission Gateway Work Instruction (WI 003)Matthew Walker – QMS, Risk Management, Usability Testing, Cybersecurity

Matthew came to us with a regulatory background that focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he now works in Medical Device Quality Management Systems, Technical/Medical Writing, and is a Lead Auditor. Matthew has updated all of our procedures for  He is currently a student in Champlain College’s Cybersecurity and Digital Forensics program, and we are proud to say that he is also a member of both the Golden Keys and Phi Theta Kappa Honor Societies! Matthew participates as a member of our audit team and has a passion for risk management and human factors engineering. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College.

Email: Matthew@FDAeCopy.com

Connect on Linkedin: http://www.linkedin.com/in/matthew-walker-214718101/