You will get a 510(k) eSTAR readiness check and an action plan
Project details
Preparing a 510(k) submission can be overwhelming, especially with FDA’s eSTAR format. This project provides a structured, single-pass review of your completed eSTAR draft to reduce the risk of delays at technical screening and highlight areas that may draw reviewer questions.
Depending on the tier, I will:
• Check answers and text for accuracy and consistency (Starter)
• Confirm attachments are properly placed and match the questions (Standard)
• Provide summary-level notes on alignment with applicable FDA guidance (Advanced)
All tiers include an Action Plan that lists identified issues, their location in eSTAR, and considerations for addressing them. This process provides predictable timelines (7 / 14 / 21 days) and clear documentation you can act on right away.
If you have any questions about scope or fit, please reach out through Upwork messaging before purchasing.
Depending on the tier, I will:
• Check answers and text for accuracy and consistency (Starter)
• Confirm attachments are properly placed and match the questions (Standard)
• Provide summary-level notes on alignment with applicable FDA guidance (Advanced)
All tiers include an Action Plan that lists identified issues, their location in eSTAR, and considerations for addressing them. This process provides predictable timelines (7 / 14 / 21 days) and clear documentation you can act on right away.
If you have any questions about scope or fit, please reach out through Upwork messaging before purchasing.
Project Type
Business Consulting, LegalWhat's included
| Service Tiers |
Starter
$1,800
|
Standard
$3,000
|
Advanced
$4,600
|
|---|---|---|---|
| Delivery Time | 7 days | 14 days | 21 days |
Number of Revisions | 0 | 0 | 0 |
Optional add-ons
You can add these on the next page.
Fast Delivery
+$900 - $1,800
30-min Q&A Call
+$200
Re-check After Updates (single pass)
(+ 5 Days)
+$500Frequently asked questions
2 reviews
(2)
(0)
(0)
(0)
(0)
This project doesn't have any reviews.
LC
Luke C.
Feb 24, 2026
Project Consultancy - Software Class Determination
LC
Luke C.
Nov 24, 2025
Project Consultancy IEC 62304
Jarrell reviewed two software documents related to ISO 62304 and provided consultancy hours. He was easy to work with, answered all our questions, and demonstrated strong expertise in medical device product development, including ISO 62304 and ISO 60601
About Jarrell
Medical Device Consultant | ISO 14971, IEC 60601, IEC 62304, 510(K)
Mars, United States - 8:24 pm local time
With over 25 years in medical device development, I provide practical guidance to translate engineering efforts into clear, compliant documentation that supports regulatory success.
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Expertise
My work spans the following compliance and documentation areas:
• Medical device risk management (ISO 14971, ISO/TR 24971, IEC/TR 80002-1)
• FDA 510(k) documentation support
• EU MDR (Regulation (EU) 2017/745) technical documentation support (including GSPR traceability)
• IEC 60601 series: Safety (60601-1), EMC (60601-1-2), Usability (60601-1-6), Alarms (60601-1-8), Home Health (60601-1-11)
• Software lifecycle processes (IEC 62304, FDA guidance)
• Human factors process support (IEC 62366-1, FDA guidance)
• Labeling & IFU requirements (ISO 15223-1, ISO 20417, 21 CFR 801, EU MDR GSPR 23)
• Standards compliance reviews and gap analysis
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Examples of Services
The examples below reflect common areas of support — I can also provide additional help depending on project needs. Feel free to reach out with specific requirements.
• Support creation and maintenance of risk management files under ISO 14971 (device hazard analysis, risk controls, traceability)
• Support verification and validation planning (bench, EMC, wireless, software, usability)
• Prepare submission-ready documentation packages
• Conduct compliance gap analyses and create remediation plans
• Support IEC 60601 certification testing with external labs
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Portfolio Highlights
In my portfolio you’ll find projects covering 510(k) submission documentation, IEC 60601 certification support, standards gap analysis & remediation, JAMA-based risk/requirements traceability, and label requirements.
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Consulting Rate
The consulting rate is flexible and can be adapted to the scope and demands of each project to ensure the right balance of value and efficiency.
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Feel free to reach out to discuss your project needs — I’m happy to explore how I can support your team.
Steps for completing your project
After purchasing the project, send requirements so Jarrell can start the project.
Delivery time starts when Jarrell receives requirements from you.
Jarrell works on your project following the steps below.
Revisions may occur after the delivery date.
Confirm intake
I’ll review what you’ve provided and confirm in messages that intake is complete.
Perform review
Review the eSTAR draft for accuracy and consistency. For Standard/Advanced, also check file placement and basic guidance alignment. I may send clarifying questions; if replies are delayed, I will proceed and note gaps.