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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 get you iso 9001, 14001, 45001, 13485, 27001 certifications
Certificação de qualidade e segurança do produto
I will prepare iso 9001, 14001, 45001 and 27001 ims documentation
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 • 7 yrs 1 mo
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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frankdigital1
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bahmanbarzingi
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“Excellent work and very professional. The MHRA registration was completed in just two days. I highly recommend her.”
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waleedjabbar1
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Strong communication. Quick turnaround and reliable. Would order again!
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abhinavmohandas
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She understood the work easily and was very easy to work with.
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villanosuy
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Well done and very professional; highly recommend it
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