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
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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.
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Canada
Ensuring compliance with Health Canada (HC) regulatory requirements to facilitate market entry for your medical devices (including In Vitro Diagnostics Devices) in Canada
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Europe
Ensuring compliance with EU MDR and EU IVDR regulatory requirements to facilitate market entry for your medical devices in European Countries
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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
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.
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
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.
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.
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.
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.