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I will develop eu mdr and iso 13485 documentation
Naveed A
Level 2
4.8
4.8
Gig Summary
About this gig
Need professional medical device documentation aligned with EU MDR and ISO 13485?
I provide customized technical and quality documentation for medical device manufacturers, importers, and distributors.
EU MDR Technical Documentation may include:
- Device Description & Intended Purpose
- Classification & GSPR Checklist
- Risk Management Documentation
- Clinical Evaluation & PMS Documentation
- Labeling & IFU
- Declaration of Conformity
- Technical Documentation
ISO 13485:2016 QMS Documentation may include:
- Quality Manual
- SOPs & Work Instructions
- Forms & Templates
- Document & Record Control
- CAPA & Complaint Handling
- Supplier Management
- Internal Audits & Management Review
- Training & Process Controls
All documentation is customized to your device, organization, processes, and applicable requirements, rather than generic templates.
Please contact me before ordering with your product details, existing documentation, and requirements so I can assess the scope and recommend the appropriate package.
Note: Scope, deliverables, timeline, and pricing depend on your specific requirements.
Get to know Naveed A
Naveed A
Medical Device Regulatory and QMS Consultant
Level 2
- FromPakistan
- Member sinceNov 2022
- Avg. response time1 hour
- Last delivery2 weeks
Languages
Urdu, English
Medical Device Regulatory and QMS Consultant with 20+ years of experience. I support medical device companies with FDA registration and listing, 510(k), EU MDR, UKCA, ISO 13485 QMS, ISO 14971 risk management, technical documentation, risk files, CER, IFU, SOPs, validation, CAPA, SCAR, audits, and regulatory compliance. I deliver practical, accurate, and audit-ready documentation tailored to your product, regulatory pathway, and business needs.
My Portfolio
Other Regulatory Compliance Consulting Services I Offer
FAQ
Do you provide both EU MDR and ISO 13485 documentation?
Yes. I provide customized documentation for EU MDR Technical Documentation and ISO 13485:2016 QMS, depending on the selected package and project scope.
Do you provide generic templates?
I can provide professionally structured templates where appropriate, but my primary service is customized documentation based on your device, organization, processes, and requirements.
Can you update our existing documentation?
Yes. I can review and revise existing documentation to address identified gaps and align it with applicable EU MDR and/or ISO 13485 requirements.
Can you review my existing QMS documentation?
Yes. I can review your existing documentation against applicable ISO 13485:2016 requirements and provide a structured gap analysis with recommendations for improvement.
Do you prepare a complete EU MDR Technical File?
Yes, where the project scope and available information support it. The exact scope and price will depend on the device, classification, documentation available, and applicable MDR requirements.
Can you prepare ISO 13485 SOPs and forms?
Yes. I can develop customized SOPs, Work Instructions, Forms, and Templates covering applicable QMS processes.
Should I contact you before ordering?
Yes. Please contact me before placing an order, particularly for complete Technical Documentation or larger QMS projects. This allows me to review your requirements and confirm the appropriate scope, timeline, and package.
Reviews
20 reviews for this Gig
| (18) | ||
| (1) | ||
| (1) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
D dolivierp
Argentina
Ongoing collaborationIts perfect to work with him
$100-$200
Price
1 day
Duration
Helpful?I ilanohayon443
United States
Ongoing collaborationAmazing work very personal
$200-$400
Price
1 day
Duration
Helpful?J jasonwrightevo
United Kingdom
Ongoing collaborationAnother excellent job from Naveed.
$400-$600
Price
3 weeks
Duration
N 
Seller's Response
Helpful?J jasonwrightevo
United Kingdom
Ongoing collaborationProfessional work and fast turnarounds.
$200-$400
Price
10 days
Duration
Helpful?M matiouze88
France
Ongoing collaborationI was truly impressed by Naveed’s professionalism and the quality of his work. He handled the entire FDA compliance process with great rigor, explaining every step clearly and answering all my questions— even the most complex ones—very quickly. His communication is outstanding, proactive, and always...
$400-$600
Price
9 weeks
Duration
N Seller's Response
Helpful?
Reviews
20 reviews for this Gig
| (18) | ||
| (1) | ||
| (1) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
D dolivierp
Argentina
Ongoing collaborationIts perfect to work with him
$100-$200
Price
1 day
Duration
Helpful?I ilanohayon443
United States
Ongoing collaborationAmazing work very personal
$200-$400
Price
1 day
Duration
Helpful?J jasonwrightevo
United Kingdom
Ongoing collaborationAnother excellent job from Naveed.
$400-$600
Price
3 weeks
Duration
N Seller's Response
Helpful?J jasonwrightevo
United Kingdom
Ongoing collaborationProfessional work and fast turnarounds.
$200-$400
Price
10 days
Duration
Helpful?M matiouze88
France
Ongoing collaborationI was truly impressed by Naveed’s professionalism and the quality of his work. He handled the entire FDA compliance process with great rigor, explaining every step clearly and answering all my questions— even the most complex ones—very quickly. His communication is outstanding, proactive, and always...
$400-$600
Price
9 weeks
Duration
N Seller's Response
Helpful?
