You will get help with medical device validation, documentation, CAPA and audit support
Project details
I am a Senior Quality Engineer and Management Representative (MR) with over 8 years of experience in the medical device industry. I provide professional consulting and documentation support for ISO 13485 Quality Management Systems, ISO 14971 Risk Management, CAPA investigations, Internal Audits, Process Validation (IQ/OQ/PQ), SOP development, and regulatory compliance activities.
My experience includes leading Quality, Engineering, New Product Development (NPD), and Operational Excellence functions for medical device manufacturing organizations. I have successfully implemented and maintained ISO 13485 compliant Quality Management Systems, supported customer and certification audits, managed validation activities, and developed technical documentation for medical device products and processes.
Whether you need assistance with audit preparation, quality documentation, CAPA investigations, risk management files, validation protocols and reports, or overall quality system improvement, I can provide practical, industry-focused solutions tailored to your requirements.
My goal is to help your organization achieve compliance, improve product quality, and maintain audit readiness.
My experience includes leading Quality, Engineering, New Product Development (NPD), and Operational Excellence functions for medical device manufacturing organizations. I have successfully implemented and maintained ISO 13485 compliant Quality Management Systems, supported customer and certification audits, managed validation activities, and developed technical documentation for medical device products and processes.
Whether you need assistance with audit preparation, quality documentation, CAPA investigations, risk management files, validation protocols and reports, or overall quality system improvement, I can provide practical, industry-focused solutions tailored to your requirements.
My goal is to help your organization achieve compliance, improve product quality, and maintain audit readiness.
Target Country
Worldwide, United States, United KingdomWhat's included
| Service Tiers |
Starter
$99
|
Standard
$299
|
Advanced
$799
|
|---|---|---|---|
| Delivery Time | 3 days | 5 days | 10 days |
Number of Projects | 1 | 1 | 1 |
General Project Consulting | |||
Define Project Goals | - | ||
Define Deliverables & KPIs | - | ||
Establish Schedule & Milestones | - | ||
Risk Management | |||
Resource Management | - | - | |
Budget Management | - | - | |
Project Reports | - | ||
Project Diagrams Provided | - | - |
Optional add-ons
You can add these on the next page.
Fast Delivery
+$50 - $200
Additional Project
(+ 2 Days)
+$125
Project Reports Provided
(+ 1 Day)
+$75
Project Diagrams Provided
(+ 1 Day)
+$50
1-Hour ISO 13485 & Medical Device Consultation
+$99Frequently asked questions
About Darshan
Medical Device Quality, Regulatory & NPD Specialist | ISO 13485 | ISO
Bengaluru, India - 6:41 pm local time
Steps for completing your project
After purchasing the project, send requirements so Darshan can start the project.
Delivery time starts when Darshan receives requirements from you.
Darshan works on your project following the steps below.
Revisions may occur after the delivery date.
Project Review & Requirement Analysis
Review project requirements, applicable standards, and available documentation.
Gap Assessment & Planning
Identify compliance gaps, define deliverables, and establish an action plan.