Clinical Evaluation for CE certification
Clinical evaluation is a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
read more510(k) Certification
A 510(k) certification is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device is safe and effective. This regulatory pathway is essential for manufacturers to legally market their medical devices in the United States.
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Years in Business
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We are dedicated to exceeding our clients’ expectations by providing exceptional services and support at every stage of the regulatory process.
RN Consulting Solutions specializes in delivering regulatory consulting services to the medical device manufacturing industry. Our mission is to simplify the regulatory landscape for our clients, ensuring compliance and facilitating seamless market access.
Our Mission
To enable clients to enter new markets with ease by providing top-notch regulatory consulting services, thereby reducing long-term costs and achieving their business goals.
Core Values
Customer First: We prioritize our customers’ needs above all.
Integrity: Upholding transparency and honesty in all our dealings.
Innovation: Continuously striving for innovative solutions to address our clients’ challenges.
We undertake the most demanding projects
