Unlock the path to regulatory success with our specialized solutions. From crafting strategic approaches to meticulously managing submissions, we guide your business through the intricate maze of regulations. With our tailored consultancy, you'll navigate complexities effortlessly, ensuring compliance and empowering your journey towards regulatory excellence.

Our Regulatory Services

Regions We Offer Our Services In

  • USA regulatory support for medical device manufacturers including FDA 510(k), De Novo, PMA and QMSR compliance.

    United States of America

    Ensuring compliance with US FDA regulatory requirements for 510(k), PMA, and de novo to facilitate market entry for your medical devices (including In Vitro Diagnostics Devices) in the USA.

    Learn More about US FDA Services
  • Health Canada regulatory consulting for medical device licensing, MDEL registration and ISO 13485 QMS compliance.

    Canada

    Ensuring compliance with Health Canada (HC) regulatory requirements to facilitate market entry for your medical devices (including In Vitro Diagnostics Devices) in Canada

    Learn More about HC Services
  • EU MDR regulatory consulting for CE Marking, technical documentation and European medical device compliance.

    Europe

    Ensuring compliance with EU MDR and EU IVDR regulatory requirements to facilitate market entry for your medical devices in European Countries

    Learn More about EU Services
  • Brazil ANVISA medical device regulatory support including RDC 751/2022 registration and GMP certification.

    Brazil

    Ensuring compliance with Brazil’s RDC 771/2022 (Medical Devices) and RDC 830/2023 (In Vitro Diagnostics Devices) to facilitate market entry for your medical devices in Brazil

    Learn More about ANVISA Services

How it works?

Step #1

We conduct an in-depth consultation to understand your product, target market, and specific regulatory needs for development of a tailored regulatory strategy based on your product specifications and market goals.

Medical device consulting brand symbol representing innovation and regulatory support across FDA, EU MDR, ANVISA and Health Canada.

Step #2

We evaluate your documentation, processes, and systems for any regulatory gaps to help prepare essential documents like Technical Files, Device Master Records, Device History Records, Clinical Data, labelling, and risk assessment

Medical device consulting brand symbol representing innovation and regulatory support across FDA, EU MDR, ANVISA and Health Canada.

Step #3

We manage the submission process, ensuring accurate document compilation and submission to regulatory authorities. We liaise with regulatory agencies, facilitating communication and addressing any issues or concerns that may arise.

Medical device consulting brand symbol representing innovation and regulatory support across FDA, EU MDR, ANVISA and Health Canada.

Step #4

Following the submission of your application, we meticulously track the progress of your application. We remain vigilant to provide comprehensive updates on your approval status and any regulatory developments.

Medical device consulting brand symbol representing innovation and regulatory support across FDA, EU MDR, ANVISA and Health Canada.

Step #5

After obtaining regulatory approval, we offer comprehensive training to drive continuous improvement and aid in maintaining compliance with ongoing regulatory requirements, including post-market surveillance and any reporting obligations.

Medical device consulting brand symbol representing innovation and regulatory support across FDA, EU MDR, ANVISA and Health Canada.

Connect With Us Now

We are eager to collaborate with you on your regulatory needs. Connect with us today for tailored solutions designed to meet your unique requirements.

Contact Us