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Sheraz H
@troy0091
Level 1
Medical Device Regulatory Expert ISO HSE EC Certification
Pakistan
Englisch, Arabisch
Über mich
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
Kompetenzen
Sheraz H
20 $/Stunde
offline •
Durchschnittliche Antwortzeit: 3 Stunden
Meine Dienstleistungen
Regulierung für Medizinprodukte
I will develop iso 13485 quality management system qms for medical devices
Technische Texte
I will create ec and ukca certificate of conformity
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20 $
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38 Bewertungen
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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...
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gee_hawk
Wiederkehrender Kunde
Großbritannien
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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weirdlywired_fl
Vereinigte Staaten
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gee_hawk
Wiederkehrender Kunde
Großbritannien
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bomasenms
Spanien
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