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I will develop iso 13485 quality management system qms for medical devices
Sheraz H
4.8
4.8
About this gig
Welcome!
I offer ISO 13485 documentation and official certification tailored for FDA, EUMDR, SFDA, Health Canada, and MDSAP. My service ensures your medical device quality management system is globally aligned and audit-ready.
⭕ Need ISO 13485 docs customized for global markets?
⭕ Want FDA, EU MDR,SFDA, or Health Canada-compliant QMS?
⭕ Ready to certify your system with one expert solution?
Why Choose Me?
Regulatory expert with global compliance know-how
Fully tailored QMS to your device type and business model
Documentation + Certification in one simple workflow
Unlimited revisions until certified
Fast delivery, NDA protected Lets navigate the regulatory landscape together.
Order now for a globally compliant ISO 13485 certification solution!
Get to know Sheraz H
Sheraz H
Medical Device Regulatory Expert ISO HSE EC Certification
- FromPakistan
- Member sinceFeb 2019
- Avg. response time1 hour
- Last delivery1 month
Languages
English, Arabic
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
My Portfolio
Other Regulatory Compliance Consulting Services I Offer
FAQ
Is the ISO 13485 certification you provide IAF-accredited?
Yes, the certification I provide comes from a certification body that is accredited by an IAF (International Accreditation Forum) member. This ensures global recognition and acceptance of your ISO 13485 certificate for regulatory submissions, tenders, and compliance audits.
Do you provide training and support after the job is completed?
Yes! I offer guidance post-delivery, including basic training and support on implementing and maintaining your ISO 13485 QMS.
What is ISO 13485 and why is it important for medical device businesses?
ISO 13485 is the internationally recognized standard for quality management systems (QMS) in the design and manufacture of medical devices, ensuring that products are consistently safe and meet regulatory and customer requirements
Can startups or small companies get certified?
Absolutely. The certification is equally accessible to small businesses and startups. With simpler organizational structures, they can often reach compliance more efficiently—with the right guidance
Are the ISO 13485 documents customized to my business and device specifications?
Yes, absolutely. All documents are fully customized to match your specific business processes, organizational structure, and medical device classifications.
Can you help me with FDA 510(k) or EU MDR Technical File?
Yes. Along with ISO 13485 QMS, I can prepare FDA 510(k) submissions, EU MDR Technical File/CE Marking documents, SFDA & Health Canada registration packages. Many Fiverr buyers request these together for a smooth compliance process.
Reviews
12 reviews for this Gig
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| (0) | ||
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Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
D 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...
$800-$1,000
Price
5 weeks
Duration
T 
Seller's Response
Helpful?N neovantis
South Africa
was very easy working with shiraz. will continue to work along side him to help achieve our company goals with regards to registration
$200-$400
Price
2 weeks
Duration
Helpful?L 
lonesomezorro
Belgium
Sheraz did a great work. I highly recommend him. Top gig . Worth the prize.
$50-$100
Price
9 days
Duration
T Seller's Response
Helpful?P princeamk
Saudi Arabia
Excellent work
$100-$200
Price
4 days
Duration
T Seller's Response
Helpful?M mesaa3d
Saudi Arabia
Professionalism of work, Quick responsiveness, and Delivery time.
$400-$600
Price
3 days
Duration
Helpful?
Reviews
12 reviews for this Gig
| (12) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
D 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...
$800-$1,000
Price
5 weeks
Duration
T Seller's Response
Helpful?N neovantis
South Africa
was very easy working with shiraz. will continue to work along side him to help achieve our company goals with regards to registration
$200-$400
Price
2 weeks
Duration
Helpful?L lonesomezorro
Belgium
Sheraz did a great work. I highly recommend him. Top gig . Worth the prize.
$50-$100
Price
9 days
Duration
T Seller's Response
Helpful?P princeamk
Saudi Arabia
Excellent work
$100-$200
Price
4 days
Duration
T Seller's Response
Helpful?M mesaa3d
Saudi Arabia
Professionalism of work, Quick responsiveness, and Delivery time.
$400-$600
Price
3 days
Duration
Helpful?
