k
komal_chaudhry

Komal Razzaq

@komal_chaudhry
4,7(42)

Level 2

Global Regulatory, and Compliance Consultant

Pakistan
Cinese, Hindi, Urdu, Spagnolo, Inglese, Tedesco
Alcune informazioni sono riportate in lingua inglese.
Chi sono
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.... Continua a leggere

Competenze

k
komal_chaudhry
Komal Razzaq
15 USD/ora
offline • 
Tempo di risposta medio: 1 ora

Consulta i miei servizi

Certificazione di sicurezza e qualità dei prodotti
I will get you iso 9001, 14001, 45001, 13485, 27001 certifications
4,7(14)
A partire da50 USD / progettoMaggiori dettagli
Certificazione di sicurezza e qualità dei prodotti
I will prepare iso 9001, 14001, 45001 and 27001 ims documentation
4,6(5)
A partire da50 USD / progettoMaggiori dettagli

Vuoi lavorare su base oraria?

Spiega a Komal Razzaq cosa ti serve.

15 USD

/

ora

Portfolio

Esperienza lavorativa

QMS Consultant

Precise GCS • Full time

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 Recensioni
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Valutazione dettagliata
  • Livello di comunicazione del venditore
    4,8
  • Qualità della consegna
    4,8
  • Valore della consegna
    4,7
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