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:
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 | Human Factors Engineering, Cybersecurity & DFIR
Matthew brings a unique background as a former Firefighter/EMT and Rope Rescue Tech with expereince in OSHA and NFPA regulations. For the better part of a decade, he has worked as a Technical/Medical Writer and Lead Auditor. He holds degrees in Fire Science and Computer Forensics and Digital Investigations, graduating Summa Cum Laude from Champlain College. Matthew is also an active member of several academic honor societies including Omicron Sigma Sigma’s Order of the Sword and Shield. His professional focus includes Human Factors Engineering, Risk Management, and Cybersecurity with a special interest in applying Digital Forensics and Incident Response (DFIR) practices to medical technology. He combines regulatory expertise with technical insige to strengthen both product safety and oranizational resiliance. He can be reached by email. You can also follow him on LinkedIn or YouTube.