RN Consulting Solutions

Empowering Medical Innovations: Navigating Regulatory Pathways with Precision and Expertise

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.

Expertise in FDA (USA), EU MDR (Europe), SFDA (MENA), and APAC regulatory requirements.

Proven track record of successful certifications and approvals.

Tailored strategies to ensure timely and cost-effective compliance.

Expertise

Providing end-to-end guidance on US FDA (510K) and CE certification, ensuring seamless regulatory compliance and market access. Our team of experts navigates the complexities of regulatory requirements to help you achieve regulatory approval efficiently and effectively.

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Quality

Delivering quality documentation and process consulting services to optimize efficiency and ensure comprehensive compliance. We focus on every detail, ensuring your submissions are accurate, complete, and meet the highest standards.

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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.

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Compliance Solutions for Every Market

Global 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.

We are a team of solution experts

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.