Viviana Gomes

Viviana Gomes Email and Phone Number

Smart MDR and 4 Easy PRRC Co-Founder | Regulatory Affairs (Medical Devices, IVD and SaMD) | Business Developer | Teacher Assistant @ 4 Easy PRRC
Viviana Gomes's Location
Coimbra, Coimbra, Portugal, Portugal
About Viviana Gomes

I am a proactive and dynamic professional with a deep passion for telerehabilitation and medical devices. These fields have always fascinated me, and I have dedicated my career to combining expertise in both areas to create meaningful solutions.๐—›๐—ผ๐˜„ ๐—ฐ๐—ฎ๐—ป ๐—œ ๐—ต๐—ฒ๐—น๐—ฝ ๐˜†๐—ผ๐˜‚? - Do you have a medical device or SaMD startup in need of regulatory guidance? - Are you part of a company or institution seeking support for the certification of medical devices or in vitro diagnostic devices (IVDs) across various markets? - Do you need assistance with the role of Person Responsible for Regulatory Compliance (PRRC)?I can assist!As a co-founder of ๐—ฆ๐—บ๐—ฎ๐—ฟ๐˜ ๐— ๐——๐—ฅ and ๐Ÿฐ ๐—˜๐—ฎ๐˜€๐˜† ๐—ฃ๐—ฅ๐—ฅ๐—–, I specialize in simplifying complex regulatory processes and ensuring compliance with international standards.๐—”๐˜ ๐—ฆ๐—บ๐—ฎ๐—ฟ๐˜ ๐— ๐——๐—ฅ:We streamline compliance processes for medical devices, IVDs, and software as medical devices (SaMD). With over 20 years of combined experience and up-to-date knowledge of global regulations, we help companies like yours meet legal requirements efficientlyโ€”ensuring your products reach the market swiftly and in full compliance.๐—”๐˜ ๐Ÿฐ ๐—˜๐—ฎ๐˜€๐˜† ๐—ฃ๐—ฅ๐—ฅ๐—–:We provide expert support for: - Representation of a Person Responsible for Regulatory Compliance - Accreditation as a PRRC - EC Representation - Commercial representation๐— ๐˜† ๐—•๐—ฎ๐—ฐ๐—ธ๐—ด๐—ฟ๐—ผ๐˜‚๐—ป๐—ฑ:I hold a Masterโ€™s degree in Biomedical Materials and Devices from the University of Aveiro and a degree in Biomedical and Electrotechnical Engineering from the Coimbra Institute of Engineering (ISEC).With a strong foundation in engineering and a passion for regulatory compliance, I am dedicated to helping businesses navigate the complexities of the medical device industry with confidence.๐—Ÿ๐—ฒ๐˜โ€™๐˜€ ๐—ฐ๐—ผ๐—ป๐—ป๐—ฒ๐—ฐ๐˜ ๐—ฎ๐—ป๐—ฑ ๐—ฒ๐˜…๐—ฝ๐—น๐—ผ๐—ฟ๐—ฒ ๐—ต๐—ผ๐˜„ ๐—œ ๐—ฐ๐—ฎ๐—ป ๐—ต๐—ฒ๐—น๐—ฝ ๐˜†๐—ผ๐˜‚ ๐—ฎ๐—ฐ๐—ต๐—ถ๐—ฒ๐˜ƒ๐—ฒ ๐˜†๐—ผ๐˜‚๐—ฟ ๐—ด๐—ผ๐—ฎ๐—น๐˜€!

Viviana Gomes's Current Company Details
4 Easy PRRC

4 Easy Prrc

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Smart MDR and 4 Easy PRRC Co-Founder | Regulatory Affairs (Medical Devices, IVD and SaMD) | Business Developer | Teacher Assistant
Viviana Gomes Work Experience Details
  • 4 Easy Prrc
    Co-Founder
    4 Easy Prrc Nov 2024 - Present
    Business Developer and Regulatory Affairs (Medical Devices, IVD and SaMD)
  • Smart Mdr
    Co-Founder
    Smart Mdr Nov 2024 - Present
  • Smart Mdr
    Co-Founder
    Smart Mdr Nov 2024 - Present
  • Medical Devices Regulatory-Support Unit
    Business Developer And Regulatory Affairs (Medical Devices, Ivd And Samd)
    Medical Devices Regulatory-Support Unit Feb 2021 - Nov 2024
    Instituto Pedro Nunes, Coimbra, Portugal
  • Instituto Superior De Engenharia De Coimbra
    Teacher Assistant
    Instituto Superior De Engenharia De Coimbra Oct 2021 - 2024

Viviana Gomes Education Details

Frequently Asked Questions about Viviana Gomes

What company does Viviana Gomes work for?

Viviana Gomes works for 4 Easy Prrc

What is Viviana Gomes's role at the current company?

Viviana Gomes's current role is Smart MDR and 4 Easy PRRC Co-Founder | Regulatory Affairs (Medical Devices, IVD and SaMD) | Business Developer | Teacher Assistant.

What schools did Viviana Gomes attend?

Viviana Gomes attended Universidade De Aveiro, Instituto Superior De Engenharia De Coimbra, Instituto Superior De Engenharia De Coimbra.

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