k
komal_chaudhry

Komal Razzaq

@komal_chaudhry
4,8(43)

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
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(15)
Certificazione di sicurezza e qualità dei prodotti
I will prepare iso 9001, 14001, 45001 and 27001 ims documentation
4,6(5)

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 4 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.

43 Recensioni
4,8

(32)
(10)
(1)
(0)
(0)
Valutazione dettagliata
  • Livello di comunicazione del venditore
    4,8
  • Qualità della consegna
    4,8
  • Valore della consegna
    4,8
1-5 di 43 recensioni
Ordina per
Più rilevante
    B

    bweissproducts

    IL

    Israele

    Collaborazione in corso
    5

    Very good work. Everything is on time and more than happy

    800 USD-1000 USD

    $

    5 settimane

    Tempo

    gig

    Certificazione di sicurezza e qualità dei prodotti

    Utile?
    Sì
    No
    F
    image-docs

    frankdigital1

    TT

    Trinidad e Tobago

    5

    Highly recommended

    200 USD-400 USD

    $

    11 giorni

    Tempo

    Utile?
    Sì
    No
    B

    bahmanbarzingi

    GB

    Regno Unito

    5

    “Excellent work and very professional. The MHRA registration was completed in just two days. I highly recommend her.”

    100 USD-200 USD

    $

    13 giorni

    Tempo

    gig

    Regolamentazione per dispositivi medici

    Utile?
    Sì
    No
    W

    waleedjabbar1

    PK

    Pakistan

    5

    Strong communication. Quick turnaround and reliable. Would order again!

    50 USD-100 USD

    $

    9 giorni

    Tempo

    gig

    Regolamentazione per dispositivi medici

    Utile?
    Sì
    No
    A

    abhinavmohandas

    IN

    India

    4,3

    She understood the work easily and was very easy to work with.

    Utile?
    Sì
    No