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Sheraz H
@troy0091
Medical Device Regulatory Expert ISO HSE EC Certification
Pakistan
Anglais, Arabe
À propos de moi
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
Compétences
Sheraz H
20 $US/heure
hors ligne •
Temps de réponse moyen de 125 heures
Voir mes services
Réglementation des dispositifs médicaux
I will develop iso 13485 quality management system qms for medical devices
Rédaction technique
I will create ec and ukca certificate of conformity
Vous souhaitez travailler sur une base horaire ?
Dites à Sheraz H ce dont vous avez besoin.
20 $US
/
heurePortfolio
37 Avis
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1 à 5 avis sur 37
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Les plus pertinents
david_tsch
Allemagne
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
Client récurrent
Royaume-Uni
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
Client récurrent
Royaume-Uni
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bomasenms
Espagne
very professional and fast.
Utile?
rachmky
Royaume-Uni
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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