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Português
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Komal Razzaq
@komal_chaudhry
Level 2
Global Regulatory, and Compliance Consultant
Paquistão
Chinês, Hindi, Urdu, Espanhol, Inglês, Alemão
Sobre mim
ISO, CE Marking, FDA, EUDAMED — if those acronyms give you a headache, you're in the right place.
I'm Komal, a QMS & regulatory compliance consultant with 7+ years helping medical device, food, and manufacturing companies get products into EU, UK, and US markets.
I handle ISO 9001/13485/14001/22000/27001/45001, CE Marking, EU MDR, FDA & MHRA registration, technical files, HACCP, and GMP.
Not sure exactly what you need? Send me a message with your product and target market. I'll tell you what's required, what's not, and how long it'll realistically take — no sales pitch.
Habilidades
Komal Razzaq
US$ 15/hora
offline •
Tempo médio de resposta: 1 hora
Conheça meus serviços
Certificação de qualidade e segurança do produto
I will do iso 9001, 14001, 45001, 13485, 27001 documentation and certifications
Certificação de qualidade e segurança do produto
I will provide iso 9001 documentation and audit ready qms support
Quer trabalhar com remuneração por hora?
Diga a Komal Razzaq o que você precisa.
US$ 15
/
horaPortfólio
Experiência profissional
QMS Consultant
Precise GCS • Período integral
Jun 2019 - Present • 6 yrs 11 mos
As a Quality Management System (QMS) Consultant, I specialize in developing and implementing documentation for international standards including ISO 9001, ISO 13485, ISO 14001, ISO 45001, ISO 22000, and ISO 27001. I help organizations build, audit, and maintain fully compliant systems aligned with EU MDR 2017/745, UK MHRA, and U.S. FDA 21 CFR 820 regulatory frameworks. My core expertise includes preparing technical documentation (risk management, clinical evaluation, IFU, labeling, and conformity assessment), managing EUDAMED SRN registration, MHRA product listing, and FDA device/establishment registration. I ensure products meet all requirements for EU, UK, and U.S. market access. Driven by precision and compliance, I bridge the gap between quality systems, product safety, and market authorization to support sustainable business growth globally.
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1-5 fora das 40 avaliações
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Strong communication. Quick turnaround and reliable. Would order again!
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