Welcome To MedoQi
Premier regulatory compliance consulting and technology firm.
Why Choose MedoQi?
Deep Expertise: Over 300 years of combined experience in quality, regulatory, Post market surveillance and clinical domain for both medical and In vitro diagnostics (IVD) devices.
Full Service: Covering all device classes, implantables, drug-device combos, and SaMD.
Flexible Approach: Onshore, offshore, or hybrid models to fit your needs.
Quality & Innovation: Committed to delivering top-tier solutions for healthcare.
Service Offerings
We specialize in providing comprehensive solutions tailored to meet the medical and IVD device industry
Our Services
Regulatory Services: Involve a wide range of activities that ensure compliance with laws and regulations, from helping companies navigate complex rules to assisting governments in enforcing them.
Post Market Services: Activities, especially for medical devices and pharmaceuticals, to monitor safety and performance after a product has been released to the market.
Complaints Handling Services: The process of receiving, documenting, and resolving customer complaints to improve products, services, and customer satisfaction
Technology Offerings
We specialize in providing comprehensive solutions tailored to the medical and IVD device industry
Our Technology
GAPSMART AI: GAPSmart Ai is currently under development and testing, set to revolutionize regulatory compliance for medtech RA and QA professionals.
MedoQi IntelliVigilance™: An advanced AI-powered platform designed to revolutionize complaints handling, vigilance reporting, and post-market surveillance (PMS) for medical devices and in-vitro diagnostics (IVDs).
MedoQi ClaimXpert Suite: ClaimXpert Suite is an advanced AI-powered platform that revolutionizes medical coding and revenue cycle management for healthcare organizations.
Partners
We work hand in hand with our partners to drive innovation, ensure compliance, and deliver quality outcomes across global markets.
Our Partners
Hoodin: Hoodin’s powerful platform helps life sciences companies manage global regulations, market surveillance, and compliance effortlessly.
BSI (Compliance Navigator): BSI’s Compliance Navigator is a comprehensive tool that simplifies regulatory compliance for medical device manufacturers.
About MedoQI
MedoQi Technologies Pvt Ltd is a premier regulatory compliance consulting and technology firm that specializes in the medical device industry. With a focus on medical devices and in vitro diagnostic device regulations, MedoQi provides expert guidance, comprehensive lifecycle support, and innovative solutions tailored to meet the unique needs of healthcare organizations.
Expert Guidance and Lifecycle Support
MedoQi excels in helping medical device companies navigate the complex regulatory landscape from the initial design phase through to post-market stages. Our services ensure efficient market entry, sustained growth, and full compliance with industry standards. By offering expert guidance in medical coding, billing, and regulatory affairs, MedoQi ensures that our clients adhere to the highest standards and best practices.
Innovative Solutions
Dedicated to driving innovation in the MedTech sector, MedoQi focuses on software development and AI-based technologies. We provide future-ready solutions that empower our clients to stay ahead in an ever-evolving market. Our strategic partnerships with healthcare organizations ensure that they can navigate regulatory compliance complexities with modern, effective solutions.
Services
We specialize in providing comprehensive solutions tailored to meet the unique needs of the medical and IVD device industry
MedoQi offers comprehensive medical device services, supporting regulatory compliance across major global markets including the EU, USFDA, TGA (Australia), Health Canada, CDSCO (India), and 75 other countries. Our services cover the entire product lifecycle, from initial design through post-market stages, ensuring adherence to international standards and efficient market entry. With specialized expertise in quality, regulatory, and clinical domains, MedoQi is your trusted partner for navigating the complexities of global medical device regulations.
MedoQi offers comprehensive IVD services, providing regulatory, analytical, clinical, and assay development support across the EU, USFDA, TGA (Australia), Health Canada, CDSCO (India), and 75 other countries. Our services cover molecular biology, clinical diagnosis, bacteriology, hematology, virology, and protein engineering. We support the entire product lifecycle, from regulatory compliance and analytical performance to clinical trials and assay development, ensuring high-quality, globally compliant IVD products.
MedoQi offers comprehensive services for drug-device combination products, ensuring seamless integration of regulatory frameworks for both drugs and devices. We provide strategic guidance on product classification, PMoA determination, and global regulatory pathways. Our expertise covers preclinical and clinical development, risk and quality management, and international registration. MedoQi also supports lifecycle management, market access strategy, and compliance with global standards, enabling successful commercialization and post-market surveillance of innovative combination products.
MedoQI specializes in the unique challenges associated with software as a medical device (SaMD). Our services include in-depth documentation for design, performance, and development, ensuring regulatory compliance for pre-market submissions. We provide critical support for software validation, verification, cybersecurity, and compliance. Our configuration and release management services guarantee that all changes in software and hardware are properly updated and managed, adhering to IEC 62304:2006/AMD 1:2015 standards for medical device software life cycle processes.
Regulatory Services
MedoQI offers a comprehensive range of regulatory services designed to support medical device manufacturers in navigating the complex landscape of global regulatory requirements.
Quality Management System (QMS) Services
A Quality Management System (QMS) encompasses a set of structured processes, policies, and procedures designed to ensure that medical devices are safe, effective, and compliant with international regulatory standards.
Medical and Clinical Writing Services
MedoQI offers a comprehensive range of clinical evaluation services designed to ensure that medical devices meet regulatory requirements and achieve market success. Our services span from strategic consulting and clinical writing to claims management and clinical file maintenance, providing end-to-end support for clinical evaluation processes.
Engineering Services
MedoQI Engineering Services offer a comprehensive suite of solutions designed to ensure the quality, safety, and compliance of medical devices throughout their lifecycle. Our expertise spans across various critical areas, including quality engineering, software as a medical device (SaMD), design quality engineering, and product risk management.
PMS and Complaints Handling
At MedoQI, we offer comprehensive Post Market Surveillance (PMS) and Complaints Handling services to ensure the continued safety, efficacy, and compliance of medical devices. Our services are designed to support manufacturers through the entire lifecycle of their products, from market introduction to post-market monitoring.
Technology
We specialize in providing comprehensive solutions tailored to meet the unique needs of the medical and IVD device industry
Our Products
Introducing GAPSmart Ai – Your Future Intelligent Regulatory Compliance Partner
GAPSmart Ai is currently under development and testing, set to revolutionize regulatory compliance for medtech RA and QA professionals. Soon, you'll be able to seamlessly navigate transitions like MDD to MDR, IVDD to IVDR, and ISO GAP Assessments. Our AI-powered tool will automate data extraction and utilization, simplifying reporting and ensuring compliance is always on point. While we finalize the details, get ready to focus on strategic tasks with GAPSmart Ai as your trusted assistant.
Automated Compliance: Streamlines data extraction
and analysis, reducing manual work and errors.
Boosted Productivity: Frees up RA and QA
professionals to focus on strategic tasks.
Seamless Transitions: Simplifies shifts from MDD to
MDR, IVDD to IVDR, and ISO GAP Assessments.
Accurate Reporting: Ensures consistent, error-free
reports across regulatory frameworks.
Cost and Time Efficiency: Cuts down on the time and
resources needed for gap assessments.
Scalable and Flexible: Adapts to various regulatory
needs and grows with your organization.
IntelliVigilance is an advanced AI-powered platform designed to revolutionize complaints handling, vigilance reporting, and post-market surveillance (PMS) for medical devices and in-vitro diagnostics (IVDs). Built on global regulatory frameworks, it seamlessly integrates automation, intelligence, and compliance to help manufacturers, authorized representatives, and healthcare organizations meet their regulatory obligations efficiently.
Automated Complaint Intake: Captures complaints
from multiple channels (emails, portals, chatbots, call
centers, social media, SMS, etc.)
Intelligent Categorization & Coding: AI-driven
classification of complaints into categories and types
aligned with IMDRF coding standards (Annexes A–F).
Regulatory Vigilance & Reportability: Automatically
evaluates complaints for regulatory reportability.
Prepares jurisdiction-specific reporting forms (e.g., EU
MIR, FDA MedWatch 3500A, CDSCO MDAE Form, Health Canada
FRM-0037, TGA MDIR)
Technical Investigation & Root Cause Analysis:
Facilitates systematic product investigations, testing,
and root cause determination. Aligns findings with IMDRF
Annex B–D for structured reporting.
Automated Workflow & Case Lifecycle Management:
End-to-end complaint tracking across lifecycle statuses:
Open → Complaint Review → Investigation → Investigation
Review → Final Review → Closed/Voided.
Global Regulatory Intelligence: Embedded knowledge
engine for country-specific vigilance timelines and
reporting obligations.
Post-Market Surveillance (PMS) & Analytics:
Real-time dashboards and trend analysis for adverse
events, device failures, and recurrence risks. Supports
PMS reporting, safety signal detection, and regulatory
inspections.
ClaimXpert Suite: Intelligent Medical Coding Automation - Coming Soon
ClaimXpert Suite is an advanced AI-powered platform that revolutionizes medical coding and revenue cycle management for healthcare organizations. Leveraging cutting-edge deep learning and natural language processing technologies, our solution delivers autonomous medical coding that eliminates manual intervention while maximizing accuracy and speed.
Industry-Leading Performance: Experience over 90%
automation rates with 95%+ coding accuracy across multiple
specialties including Emergency Department, Primary Care,
Radiology, Surgery, and more. Reduce coding turnaround
times from days to minutes while cutting operational costs
by up to 40%.
Built for Healthcare: ClaimXpert Suite maintains
the highest standards for security and compliance, with
HIPAA adherence and SOC 2 certification. Our closed-loop
AI architecture ensures your patient data remains
protected while delivering touchless coding automation.
The Smart Choice for Modern Healthcare: Whether
you're a large health system, physician group, or revenue
cycle management firm, ClaimXpert Suite scales to meet
your needs. Say goodbye to coding backlogs, staffing
challenges, and revenue leakage. Empower your organization
with intelligent automation that works 24/7, ensuring
faster reimbursements, improved cash flow, and allowing
your team to focus on what matters most—patient care.
Experience the future of medical coding with ClaimXpert
Suite. Coming Soon.
Hoodin’s powerful platform helps life sciences companies manage global regulations, market surveillance, and compliance effortlessly.
Customised Regulatory Intelligence: Tailored lists
of relevant global regulations, directives, and
standards.
Real-Time Updates: Instant alerts on regulatory
changes impacting your product.
AI-Driven Insights: AI summarises regulatory
updates and their implications.
Standards Tracking: Track changes to relevant
global standards and harmonisation efforts.
24/7 Post-Market Surveillance: Monitor safety,
clinical trials, and adverse events in real-time.
Technology & Innovation Monitoring: Stay ahead with
insights on emerging tech and patents.
Collaborative Reporting: Customise reports and
collaborate easily within your team.
BSI Compliance Navigator
BSI Compliance Navigator is an advanced digital platform designed to help medical device and in-vitro diagnostic (IVD) manufacturers stay up to date and compliant with global regulatory requirements. Developed by the British Standards Institution (BSI), this intuitive tool provides centralized access to essential standards, regulations, and guidance documents relevant to the medical and healthcare industry.
Advanced Notifications: Put your team on the front
foot, with alerts for when standards change and advance
warnings for upcoming changes to BS standards.
Smart Search: Search by device type or keyword to
find every relevant standard, guidance document and
regulation. Filter by publisher, region and more.
Expert Commentary: Industry expert commissioned
content which provide the user with a guide to the
standard. It includes an overview of what the standard is
about, an explanation of any challenging or complex
concepts or requirements, and guidance on the relationship
with the standard and its portfolio, and the wider
regulatory environment.
Tracked Changes: Redlined versions of standards
which contain the marked-up changes between versions. Red
lines are used to cross out anything that has been removed
from the previous version and highlighting in green is
used to indicate new additions.
Extended Consulting Partners
We collaborate with trusted global partners who share our commitment to innovation, quality, and regulatory excellence. Together, we deliver reliable and compliant solutions that help our clients succeed in dynamic markets.
MedoQi Expertise with Global Regulatory Agencies
MedoQi’s team has provided regulatory support across a wide range of global regulatory agencies, including:
Meet Our Team
At MedoQi, our strength lies in our dedicated and highly skilled team of professionals who bring a wealth of experience and expertise to the table. Comprising industry leaders in regulatory affairs, quality management, clinical research, and technology, our team is united by a common goal: to deliver innovative, high-quality solutions that enhance patient safety and health outcomes.
Vithyalakshmi S
CEO & Co Founderwe are dedicated to enhancing the quality and safety of medical devices worldwide.
Indira S
CMO & Co FounderAs the Chief Marketing Officer and Co-Founder of MedoQI, I am thrilled to welcome you to our platform.
Adiyaman Annathurai
CTO & Co FounderDriving Tech Innovation as Co-founder & CTO | Building AI Platforms to Solve Complex Challenges in MedTech and Gaming
Dr. Kumar A
Senior DirectorGlobal MedTech Quality, Regulatory & Clinical Practice
Martin King
Senior Consultant and Advisor
Dr. Sathesh Kumar Annamalai
Consultant and Advisor
Dr. Vasantha Priya MBBS
Clinical Evidence Specialist - Devices
Vinoth Ganesan
Technical Manager
SAKTHIVEL T
Sr Business Development Manager
Anjali Negi
Manager Business DevelopmentConsultant - SME/MR
Dr. T. Senthil Kumar MS, DNB, MCH
Consultant - Urology
Dr. Sathish Kumar MD
Consultant - Clinical Trials
Dr. J. Saravanan MS(Gen Surgery) MCH
Consultant - Urology/Nephorology
Dr. S.N.Meenakshi Sundari MD
Consultant (General Medicine)Global Offices
Having multiple locations means we don't just spread our wings; we create a sky where everyone can soar
Chennai (HO)
RMZ, Millenia Business Park Campus 1A, No 143, Chennai, 600096 Tamilnadu, India
+91-44-46900555, info@medoqi.com
Bengaluru
Siddapura, Whitefield, Bengaluru, 560066 Karnataka, India
+91 9943326555, asiasales@medoqi.com