Global Medical Device Regulatory Excellence
Expert regulatory affairs consulting for medical device manufacturers, distributors, and importers navigating complex worldwide compliance requirements with precision and confidence.
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Comprehensive Regulatory Affairs Consulting
Satish Mehra brings decades of specialized expertise in medical device regulatory affairs, guiding manufacturers and distributors through the intricate landscape of global compliance. Our consulting services streamline approval processes, reduce time-to-market, and ensure your medical devices meet stringent regulatory standards across multiple jurisdictions.
From initial concept to commercial launch, we provide strategic guidance that transforms regulatory challenges into competitive advantages, helping you achieve successful market entry worldwide.
Worldwide Regulatory Expertise
North America
FDA compliance, 510(k) submissions, PMA applications, and Quality System Regulation (QSR) guidance for U.S. and Canadian markets.
European Union
CE marking, MDR compliance, technical documentation, and authorized representative services for EU member states.
Asia-Pacific
Registration support for China NMPA, Japan PMDA, South Korea MFDS, and other key Asian regulatory bodies.
Emerging Markets
Strategic entry planning for Latin America, Middle East, Africa, and developing regulatory environments worldwide.
Services for Medical Device Manufacturers
01
Regulatory Strategy Development
Comprehensive regulatory roadmaps tailored to your device classification, target markets, and business objectives for optimal market access.
02
Submission Preparation
Expert preparation of 510(k), PMA, De Novo, CE technical files, and other critical regulatory submissions with meticulous attention to detail.
03
Quality Management Systems
ISO 13485 implementation, audit preparation, and continuous compliance monitoring to maintain regulatory good standing globally.
04
Post-Market Surveillance
Vigilance reporting, complaint handling, corrective actions, and ongoing regulatory intelligence to ensure sustained compliance.
Import Solutions for Distributors
Streamlined Import Processes
Navigate complex import regulations with confidence. We provide comprehensive support for medical device distributors seeking to import products across international borders, ensuring full compliance with local requirements.
  • Import license applications and maintenance
  • Customs classification and documentation
  • Local agent representation services
  • Product registration and renewal management
  • Regulatory liaison with government authorities
Why Partner With Us
Proven Expertise
Decades of hands-on experience navigating regulatory pathways for devices ranging from Class I to Class III across multiple continents.
Global Network
Established relationships with regulatory authorities worldwide, ensuring efficient communication and faster approval timelines for your products.
Tailored Strategies
No cookie-cutter approaches. Every regulatory plan is customized to your specific device, market goals, and resource constraints.
Results-Driven
Our success is measured by yours. We focus on achieving approvals efficiently while minimizing delays and unexpected regulatory obstacles.
Our Regulatory Process
1
Initial Assessment
Comprehensive evaluation of your device, intended markets, and regulatory requirements to establish a clear pathway forward.
2
Strategy Development
Creation of detailed regulatory roadmap with timelines, milestones, and resource allocation for optimal efficiency.
3
Documentation
Meticulous preparation of all required technical documentation, clinical evidence, and regulatory submissions.
4
Submission & Review
Strategic submission timing and proactive engagement with regulatory authorities to address questions efficiently.
5
Approval & Launch
Post-approval support including market launch guidance and ongoing compliance maintenance.
Regulatory Success Metrics
25+
Years Experience
Deep regulatory expertise across evolving global standards
50+
Countries Served
Worldwide regulatory submissions and approvals
200+
Devices Approved
Successful regulatory clearances and certifications
95%
First-Time Success
High approval rate without major deficiencies
Industries & Device Categories
Diagnostic Equipment
  • In vitro diagnostics
  • Imaging systems
  • Point-of-care devices
  • Laboratory instruments
Therapeutic Devices
  • Surgical instruments
  • Implantable devices
  • Drug delivery systems
  • Therapeutic equipment
Connected Health
  • Digital health platforms
  • Wearable devices
  • Remote monitoring
  • Software as medical device
We provide regulatory consulting across the full spectrum of medical device classifications, from simple Class I devices to complex Class III implantables and cutting-edge digital health solutions. Our expertise spans traditional medical equipment, innovative therapeutic technologies, and emerging connected health platforms.
Ready to Navigate Global Regulatory Requirements?
Start Your Regulatory Journey Today
Whether you're a medical device manufacturer seeking FDA approval, a distributor importing products internationally, or an innovator launching a breakthrough technology, expert regulatory guidance makes the difference between delays and success.
Contact us to discuss your regulatory needs and discover how our worldwide consulting services can accelerate your path to market while ensuring full compliance with global standards.
Contact Person Satish Mehra
Whatsapp Now - +918920964801
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