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Sheraz H
@troy0091
Medical Device Regulatory Expert ISO HSE EC Certification
Pakistan
English, Arabic
About me
With over a decade of expertise, I offer specialized medical device regulatory services, ISO documentation, and compliance. As an IRCA Approved Lead Auditor for ISO 9001:2015 & ISO 13485:2016, I ensure top-tier standards. Proficient in navigating MDR 2017/745, MDD, FDA, cGMP, and ISO standards, I provide tailored compliance strategies, including technical writing and global regulatory affairs. My expertise extends to HSE plans and SFDA documentation, making me a reliable partner for sustained success.
#MedicalDevices #ISO
Skills
Sheraz H
$20/hour
Offline •
Average response time: 125 hours
See my services
Medical Device Regulatory
I will develop iso 13485 quality management system qms for medical devices
Technical Writing
I will create ec and ukca certificate of conformity
Want to work on an hourly basis?
Tell Sheraz H what you need.
$20
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hourPortfolio
37 Reviews
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Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
1-5 out of 37 Reviews
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david_tsch
Germany
Very positive experience. The architecture of the delivered QMS package is coherent and genuinely strong where it matters most: an above-average traceability matrix, an algorithm-validation SOP at state-of-the-art level, and a cleanly designed outsourced-manufacturing concept including the full IVDR...
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gee_hawk
Repeat Client
United Kingdom
Sheraz did a great job, he went above and beyond and delivered some fantastic work, would definitely use again and would recommend to anyone.
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gee_hawk
Repeat Client
United Kingdom
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bomasenms
Spain
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rachmky
United Kingdom
Sheraz was able to register my product with the MHRA and simplified this process. He was very professional and polite and understood my requirements. We will work together on my next application. Highly recommend
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