Instructions on how to create an electronic submission gateway (ESG) for electronic submissions of a medical device report (MDR) to the FDA.
Electronic submission gateway work instruction is available for $199.00:
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.
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:
- SYS-018, Customer Feedback & Complaint Handling Procedure
- SYS-020, Recalls & Advisory Notices
- SYS-029, Medical Device Reporting Procedure
- SYS-035, Mandatory Problem Reporting
- SYS-036, Vigilance Reporting Procedure
About the Author
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.
Connect on Linkedin: http://www.linkedin.com/in/matthew-walker-214718101/