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Sheraz H
@troy0091
Medical Device Regulatory Expert ISO HSE EC Certification
Pakistan
Inglese, Arabo
Chi sono
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
Competenze
Sheraz H
20 USD/ora
offline •
Tempo di risposta medio: 125 ore
Consulta i miei servizi
Regolamentazione per dispositivi medici
I will develop iso 13485 quality management system qms for medical devices
Scrittura tecnica
I will create ec and ukca certificate of conformity
Vuoi lavorare su base oraria?
Spiega a Sheraz H cosa ti serve.
20 USD
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oraPortfolio
37 Recensioni
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- Qualità della consegna
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1-5 di 37 recensioni
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Più rilevante
david_tsch
Germania
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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Utile?
gee_hawk
Cliente abituale
Regno Unito
Sheraz did a great job, he went above and beyond and delivered some fantastic work, would definitely use again and would recommend to anyone.
Risposta del venditore
Utile?
gee_hawk
Cliente abituale
Regno Unito
Risposta del venditore
Utile?
bomasenms
Spagna
Utile?
rachmky
Regno Unito
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
Utile?
