k
komal_chaudhry

Komal Razzaq

@komal_chaudhry
4,7(42)

Level 2

Global Regulatory, and Compliance Consultant

Paquistão
Chinês, Hindi, Urdu, Espanhol, Inglês, Alemão
Algumas informações são exibidas no idioma inglês.
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.... Saiba mais

Habilidades

k
komal_chaudhry
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
4,7(14)
A partir deUS$ 50 /projetoMais detalhes
Certificação de qualidade e segurança do produto
I will prepare iso 9001, 14001, 45001 and 27001 ims documentation
4,6(5)
A partir deUS$ 50 /projetoMais detalhes

Quer trabalhar com remuneração por hora?

Diga a Komal Razzaq o que você precisa.

US$ 15

/

hora

Portfólio

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.

42 Avaliações
4,7

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Classificação detalhada
  • Nível de comunicação do freelancer
    4,8
  • Qualidade da entrega
    4,8
  • Valor da entrega
    4,7
1-5 fora das 42 avaliações
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