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I will develop complete eu UK mdr technical file regulatory support
ISO 13485, MDR 2017 745, FDA Regulatory Affairs, Medical Device QMS Expert
Hi, Greetings!
I am a Medical Device Regulatory and QMS expert with over 20 years of experience in regulated industries. I am an IRCA Approved Lead Auditor for ISO 9001:2015 & ISO 13485:2016 and speci...
Level 2
Has met high performance criteria and has a proven track record for meeting client expectations.
About this Gig
Hello and Greetings!
Compliance with regulatory standards such as ISO 13485:2016, EU MDR 2017/745, and IVDR 2017/746 is essential for medical device approval and market access. These regulations require complete and well-structured technical documentation, including Risk Management, Clinical Evaluation, PMS, and PMCF.
I provide professional Medical Device Regulatory Affairs and Technical Documentation services to ensure full compliance with global requirements.
Services Include:
Technical Documentation for EU MDR 2017/745 & IVDR 2017/746
ISO 13485:2016 QMS documentation development
Technical documentation support for UK MDR 2002
Clinical Evaluation Reports (CER) per MEDDEV 2.7/1 Rev. 4
Biological Evaluation Reports (BER) per ISO 10993-1:2018
Risk Management, PMS & PMCF documentation
All documents are prepared in a structured, audit-ready, and compliant format tailored to your device.
Additionally, I offer:
MHRA product registration support
ISO 13485:2016 QMS documentation
End-to-end regulatory support until Notified Body certification
Feel free to place an order or contact me before startingIm here to assist you.
My Portfolio
FAQ
Are your prices fixed for the projects as mentioned in your gig?
No, the prices may vary depending on the type of work you require.
Do you classify the devices into class?
Yes, I can do it but it's better that you provide this detail as the documentation is based on the device's classification.
Reviews
2 reviews for this Gig
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Y yeomans888
United Kingdom
Naveed knows his stuff and is efficient, I'll be working again with Naveed as its import to have someone whom understands the technical aspect of compliance!
$50-$100
Price
1 day
Duration
Helpful?B 
brokenchief
Repeat Client
United Kingdom
Naveed has been a dream to work with. Very professional and will definitely be using again!
N 
Seller's Response
Helpful?
Reviews
2 reviews for this Gig
| (2) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
Y yeomans888
United Kingdom
Naveed knows his stuff and is efficient, I'll be working again with Naveed as its import to have someone whom understands the technical aspect of compliance!
$50-$100
Price
1 day
Duration
Helpful?B brokenchief
Repeat Client
United Kingdom
Naveed has been a dream to work with. Very professional and will definitely be using again!
N Seller's Response
Helpful?
