Why Choose RN Consulting Solutions?
Navigating the complex regulatory landscape for medical devices can be challenging, especially when targeting multiple markets. At RN Consulting Solutions, we specialize in providing end-to-end regulatory compliance solutions tailored to your needs. Whether you’re seeking FDA 510(k) clearance, CE Marking under EU MDR, or approvals in MENA and APAC regions, our team of experts is here to guide you every step of the way.

Commitment
Dedicated to fostering employment opportunities and economic growth in rural India, thereby making a positive social impact. We are committed to empowering communities by creating sustainable jobs and providing valuable training and development opportunities.
read moreGlobal Regulatory Expertise
Every region has its own regulatory requirements, and our team is well-versed in the nuances of each.
USA
- 510(k) Submissions
- Pre-Submission Meetings with FDA
- De Novo Classification
- PMA (Premarket Approval) Support
Europe
- CE Marking under EU MDR/IVDR
- Technical Documentation Preparation
- Clinical Evaluation Reports (CERs)
- Post-Market Surveillance (PMS)
MENA
- SFDA (Saudi Food and Drug Authority) Approval
- GCC (Gulf Cooperation Council) Certification
- Local Authorized Representative (LR) Services
APAC
- China NMPA (National Medical Products Administration) Registration
- India CDSCO (Central Drugs Standard Control Organization) Approval
- Japan PMDA (Pharmaceuticals and Medical Devices Agency) Certification
- Australia TGA (Therapeutic Goods Administration) Compliance
Industry Expertise
Leveraging deep knowledge and extensive experience to provide end-to-end guidance on US FDA (510K) and CE certification processes.
Quality Assurance
We ensure every aspect of your regulatory submissions is accurate, complete, and adheres to the highest standards.
After Sales
Our team ensures continuous compliance, updates on regulatory changes, and prompt resolution of any post-market challenges.
Client-Centric Approach
Our focus on integrity and innovation allows us to offer tailored solutions that address the unique challenges faced by each client.

Ready to Achieve Regulatory Compliance?
Whether you’re launching a new medical device or expanding into new markets, we’re here to help. Contact us today to schedule a free consultation and take the first step toward global compliance.





