I3CGLOBAL – Premier Regulatory Consulting Firm for Medical Devices & Healthcare
I3CGLOBAL is a leading global regulatory consulting firm specializing in medical device regulatory approvals, compliance, and quality assurance. With a strong presence in the healthcare sector, the company provides expert guidance on international regulatory frameworks, helping manufacturers successfully navigate FDA, CE Marking, UKCA, and ISO certifications.
Company Overview
- Headquarters: Bengaluru, India
- Industry: Medical Device Regulatory Consulting
- Core Services: FDA 510(k) Submission, CE Marking, ISO 13485, Risk Management
- Global Reach: Clients across North America, Europe, Asia, and the Middle East
Service Portfolio
I3CGLOBAL offers a comprehensive range of regulatory compliance and quality assurance services:
1. Regulatory Consulting
- FDA 510(k) Submission – Comprehensive support for obtaining U.S. FDA clearance for medical devices.
- CE Marking Assistance – Ensuring compliance with EU MDR (2017/745) for European market entry.
- UKCA Marking – Guidance on UK regulatory requirements post-Brexit.
2. Quality Assurance & Certification
- ISO 13485 Implementation – Assisting medical device manufacturers in obtaining ISO 13485 certification for quality management.
- GMP Compliance – Helping companies meet Good Manufacturing Practices (GMP) in various jurisdictions.
3. Data Security & Compliance
- ISO 27001 Certification – Ensuring secure handling of sensitive healthcare data.
- HIPAA Compliance – Helping U.S. healthcare companies meet Health Insurance Portability and Accountability Act regulations.
4. Documentation & Risk Management
- Technical File Preparation – Complete regulatory documentation for product approvals.
- Risk Management Documentation – Compliance with ISO 14971 for medical device risk assessment.
5. Electronic Submissions
- eCTD Submissions – Electronic Common Technical Document (eCTD) services for streamlined regulatory filings.
- FDA eCopy Services – Formatting and submission of electronic regulatory documents.
6. Clinical Evaluation & Post-Market Surveillance
- Clinical Data Analysis – Evaluating real-world evidence to support regulatory filings.
- Post-Market Surveillance (PMS) – Continuous monitoring of device safety and efficacy.
Market Position & Growth
I3CGLOBAL has established itself as a trusted regulatory partner for medical device manufacturers, pharmaceutical companies, and biotech firms worldwide.
- Global Client Base: Over 500+ clients spanning 30+ countries.
- Regulatory Success Rate: 95%+ approval rate across multiple regulatory authorities.
- Annual Revenue: Estimated at $10 million USD.
Key Achievements & Recognitions
- Certified Regulatory Consultant (2023) – Recognized by global medical device associations.
- Top 10 Regulatory Consulting Firms (2022) – Ranked among the leading regulatory firms in Asia.
- 500+ Successful FDA 510(k) Submissions – Ensuring smooth market entry for global clients.
Compliance & Certification Capabilities
I3CGLOBAL specializes in international regulatory frameworks and maintains a 100% compliance success rate across multiple standards:
- ISO 13485 – Medical Device Quality Management
- ISO 14971 – Risk Management for Medical Devices
- EU MDR 2017/745 – European Medical Device Regulation
- FDA 21 CFR Part 820 – Quality System Regulations for Medical Devices
- HIPAA – U.S. Healthcare Data Security Compliance
Client Testimonials
✔️ “I3CGLOBAL's expertise in FDA 510(k) submissions was instrumental in our successful market entry. Their team provided top-notch guidance throughout the process.” – CEO, U.S. Medical Device Manufacturer
✔️ “Their CE Marking support was invaluable for our expansion into Europe. Highly recommend their regulatory services!” – Regulatory Affairs Director, European Biotech Company
Future Outlook
I3CGLOBAL is focused on expanding its regulatory support services to cover emerging markets and new medical technologies. The company is investing in AI-driven compliance solutions and digital regulatory filing systems to enhance efficiency and accuracy.
With its strong regulatory expertise, high success rate, and global client base, I3CGLOBAL continues to be a trusted partner for medical device and healthcare companies worldwide.
