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I will develop iso 13485 quality management system qms for medical devices
Sheraz H
Level 2
4,8
4,8
Über diesen Service
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!
Lerne Sheraz H kennen
Sheraz H
Medical Device Regulatory Expert ISO HSE EC Certification
Level 2
- AusPakistan
- Mitglied seitFeb. 2019
- ⌀ Antwortzeit1 Stunde
- Letzte Lieferung3 Wochen
Sprachen
Englisch, Arabisch
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
Mein Portfolio
Meine weiteren Dienstleistungen im Bereich Beratung zur Einhaltung gesetzlicher Vorschriften
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.
Bewertungen
12 Bewertungen für diesen Service
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Zusammensetzung der Bewertung
- Kommunikation
- Qualität der Lieferung
- Preis-Leistungs-Verhältnis der Lieferung
Sortieren nach:
Am relevantesten
D david_tsch
Deutschland
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 $
Preis
5 Wochen
Dauer
T 
Antwort des Freelancers
Hilfreich?N neovantis
Südafrika
was very easy working with shiraz. will continue to work along side him to help achieve our company goals with regards to registration
400 $-600 $
Preis
2 Wochen
Dauer
Hilfreich?L 
lonesomezorro
Belgien
Sheraz did a great work. I highly recommend him. Top gig . Worth the prize.
50 $-100 $
Preis
9 Tagen
Dauer
T Antwort des Freelancers
Hilfreich?P princeamk
Saudi-Arabien
Laufende ZusammenarbeitExcellent work
200 $-400 $
Preis
4 Tagen
Dauer
T Antwort des Freelancers
Hilfreich?M mesaa3d
Saudi-Arabien
Professionalism of work, Quick responsiveness, and Delivery time.
600 $-800 $
Preis
3 Tagen
Dauer
Hilfreich?
Bewertungen
12 Bewertungen für diesen Service
| (12) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Zusammensetzung der Bewertung
- Kommunikation
- Qualität der Lieferung
- Preis-Leistungs-Verhältnis der Lieferung
Sortieren nach:
Am relevantesten
D david_tsch
Deutschland
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 $
Preis
5 Wochen
Dauer
T Antwort des Freelancers
Hilfreich?N neovantis
Südafrika
was very easy working with shiraz. will continue to work along side him to help achieve our company goals with regards to registration
400 $-600 $
Preis
2 Wochen
Dauer
Hilfreich?L lonesomezorro
Belgien
Sheraz did a great work. I highly recommend him. Top gig . Worth the prize.
50 $-100 $
Preis
9 Tagen
Dauer
T Antwort des Freelancers
Hilfreich?P princeamk
Saudi-Arabien
Laufende ZusammenarbeitExcellent work
200 $-400 $
Preis
4 Tagen
Dauer
T Antwort des Freelancers
Hilfreich?M mesaa3d
Saudi-Arabien
Professionalism of work, Quick responsiveness, and Delivery time.
600 $-800 $
Preis
3 Tagen
Dauer
Hilfreich?
