You will get EU MDR Review & ISO 13485 Compliance Support (GSPR | QMS)
Top Rated
Project details
I provide expert regulatory and compliance support for companies working under EU MDR, ISO 13485, Class I–IIa–IIb–III devices, and Notified Body expectations. With over 20 years of QA & Compliance experience in multinational pharmaceutical and medical device environments, I help clients quickly identify regulatory gaps, strengthen their QMS, and prepare for inspections or submissions.
This project delivers a precise and actionable MDR Gap Assessment, covering Technical Documentation, Annex I General Safety & Performance Requirements, risk management alignment (ISO 14971), QMS compliance (ISO 13485), CAPA effectiveness, post-market documentation, and notified-body audit readiness.
You will receive clear findings, corrected documentation (when applicable), and prioritized next steps, written in professional regulatory language and fully aligned with EU MDR and global regulatory practices.
My objective is simple: reduce compliance risk, increase audit readiness, and support your team with high-quality, reliable regulatory expertise.
This project delivers a precise and actionable MDR Gap Assessment, covering Technical Documentation, Annex I General Safety & Performance Requirements, risk management alignment (ISO 14971), QMS compliance (ISO 13485), CAPA effectiveness, post-market documentation, and notified-body audit readiness.
You will receive clear findings, corrected documentation (when applicable), and prioritized next steps, written in professional regulatory language and fully aligned with EU MDR and global regulatory practices.
My objective is simple: reduce compliance risk, increase audit readiness, and support your team with high-quality, reliable regulatory expertise.
Project Type
Business Consulting, Legal, Training & DevelopmentWhat's included
| Service Tiers |
Starter
$85
|
Standard
$310
|
Advanced
$510
|
|---|---|---|---|
| Delivery Time | 3 days | 6 days | 10 days |
Number of Revisions | 0 | 1 | 2 |
Optional add-ons
You can add these on the next page.
Fast Delivery
+$36 - $275
Additional Revision
+$45
Regulatory Consultation Call (30 min)
+$95
Fast Delivery
(+ 2 Days)
+$150
Additional Revision
(+ 1 Day)
+$45Frequently asked questions
1 review
(0)
(1)
(0)
(0)
(0)
This project doesn't have any reviews.
GA
Gal A.
Mar 27, 2026
MHRA Medical Device Technical File + Registration Expert Needed (UK)
About Efrain
FDA / EU MDR Regulatory & eQMS Consultant | Pharma, MedTech, SaMD & AI
100%
Job Success
Argentina, Argentina - 2:19 pm local time
My work focuses on translating regulatory frameworks: FDA, EMA, MHRA, EU MDR and global GMP, into practical, operational systems including QMS architecture, eQMS implementation, audit readiness programs, technical documentation structures and compliance strategies.
I typically support companies in situations such as:
• Preparing for FDA, EMA or MHRA inspections and audits
• Building or remediating Quality Management Systems (QMS / eQMS)
• Developing regulatory documentation and technical files for medical devices and SaMD
• Strengthening compliance infrastructure for global market expansion
Clients engage me when regulatory complexity becomes a strategic barrier to growth.
Steps for completing your project
After purchasing the project, send requirements so Efrain can start the project.
Delivery time starts when Efrain receives requirements from you.
Efrain works on your project following the steps below.
Revisions may occur after the delivery date.
Kickoff & Documentation Intake
I review your uploaded documents (QMS, SOPs, technical files, CAPAs, deviations) and confirm device class, MDR Annexes, and regulatory scope before starting the assessment.
Regulatory & MDR Gap Assessment
I identify gaps, inconsistencies, missing evidence, and nonconformities against EU MDR, ISO 13485, Annexes I–XI, and Notified Body expectations. Findings are documented clearly and precisely.