Marketing your medical device requires obtaining regulatory approval in each country, which can be challenging due to varying requirements. Registration may involve meeting premarket technical and clinical requirements, or leveraging existing approvals for faster market access.

At RABT Global, we understand the complex and ever-changing regulatory landscape for medical devices. That’s why we offer comprehensive medical device registration services to help you bring your products to market faster and more efficiently.

Our team of experienced regulatory experts can help you with every aspect of the registration process, from understanding the specific requirements of each country to preparing and submitting your documentation. We also offer ongoing support to help you maintain compliance with changing regulations.

Our services

• Regulatory gap assessment
• Registration strategy
• Documentation preparation
• Submission and follow-up
• Ongoing support

Markets we support:

• North American registration consulting for medical devices and IVDs

• North America: Medical device and IVD registration, including premarket submissions and quality systems compliance.
• Latin America: Medical device and IVD registration, including regulatory translation and assistance with local regulatory authorities.
• EMEA: Medical device and IVD registration, including compliance with MDR/IVDR and other European regulations.
• Asia Pacific: Medical device and IVD registration, including assistance with local regulatory authorities and market access strategies.

Contact us today to learn more about our medical device registration services and how we can help you bring your products to market faster and more efficiently. Contact us.