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$
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I will write technical documentation for medical devices
"I help businesses work smarter with AI and deliver polished content"
Struggling to find someone who delivers professional quality fast?
I'm Fereg — a compliance professional with 10+ years working with global medical device companies, now combining deep expertise with ...
About this Gig
- Prepare technical file documentation and quality system documents of medical devices Class I, Class IIa and Class IIb for compliance to EU MRD 2017/745. Create QMS to ISO 13485:2016 processes and procedures.
- I am an experienced regulatory affairs specialist on medical devices and healthcare products. I have prepared technical documentation for regulatory submission globally
- I have 16 years experience in production, quality control, regulatory documentation medical devices
- Quality Management System according to ISO 13485:2016
- Technical Documentation according to EU MDR 2017/745
- EU Declaration of Conformity
- Clinical Evaluation Report according to MEDDEV 2.7/1 rev 4: Literature search and evaluation
- Creation of Post Market Surveillance Plan and Report
- Vigilance System Procedure
- Risk Analysis Management according to ISO 14971:2012
- Design History File
- Standard Operating Procedure, Work Instructions, Forms
- Your device full description; its intended use and purpose
- Any accessories with the device or special features
Document type:
Documentation
•
Regulatory Documents
Industry:
Medical & biotech
Language:
English
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
Reviews
3 reviews for this Gig
| (3) | ||
| (0) | ||
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Rating Breakdown
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- Recommend to a friend
- Service as described
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S stevelugtigheid
Canada
Good quality work in the time we agreed to.
H 
Seller's Response
Helpful?R rainerr
United Kingdom
After resea importing medical devices, I was left with more questions than answers. It truly is a difficult field to get to grips with, so I approached hammersmith19 from a total newbie's perspective and asked for a custom gig. I wanted to know the steps I needed to take from the ground up in order to...
Helpful?B bobthenoob678
Philippines
Thanks for the patience it was a long ride , everything was delivered as promised in time and 100% accurate ... thumbs up
H Seller's Response
Helpful?
Reviews
3 reviews for this Gig
| (3) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Recommend to a friend
- Service as described
Sort By
Most relevant
S stevelugtigheid
Canada
Good quality work in the time we agreed to.
H Seller's Response
Helpful?R rainerr
United Kingdom
After resea importing medical devices, I was left with more questions than answers. It truly is a difficult field to get to grips with, so I approached hammersmith19 from a total newbie's perspective and asked for a custom gig. I wanted to know the steps I needed to take from the ground up in order to...
Helpful?B bobthenoob678
Philippines
Thanks for the patience it was a long ride , everything was delivered as promised in time and 100% accurate ... thumbs up
H Seller's Response
Helpful?
