Medical Device Regulatory Consulting
A premier consulting firm offering specialized FDA 510k, EU MDR, and ISO 13485 consulting services for the Medical Device sector. We fortify your path to the global market.
Your Partner in Medical Device Compliance
RiviaMed provides expert medical device regulatory consulting and quality management system support. From initial concept to post-market surveillance, our regulatory affairs consulting ensures your products meet global compliance standards for FDA, EU MDR, and more, helping you reach patients safely.
Our Core Strengths
Why leading innovators trust RiviaMed.
Medical Device Exclusive Focus
Our specialization ensures deep, relevant expertise for your projects.
25+ Years of Strategic Insight
Leverage decades of industry leadership to navigate complex challenges.
Lean & Agile Service Delivery
We provide efficient, flexible, and scalable solutions tailored to your needs.
Comprehensive Service Offerings
End-to-end support across the full product lifecycle.
Navigate global regulations with our expert strategy and submission support.
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Build and maintain a robust Quality Management System compliant with international standards.
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Integrate compliance from the start with our design control and risk management expertise.
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Ensure your product documentation and processes are precise and up-to-date.
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Our credentials are a testament to our commitment to excellence.
Global Market Access
We have extensive experience working with major global health authorities to secure market approval for your devices.