Welcome to MedoQi – Regulatory Compliance Consulting for Medical & IVD Devices
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
Medical Devices
Regulatory compliance across the EU, USFDA, TGA, Health Canada, CDSCO, and 75+ other countries, covering the entire product lifecycle.
Learn MoreIn Vitro Diagnostic (IVD) Devices
Regulatory, analytical, clinical, and assay development support across molecular biology, hematology, virology, and more.
Learn MoreDrug-Device Combination Products
Product classification, PMoA determination, and global regulatory pathways for combination products.
Learn MoreSoftware as a Medical Device (SaMD)
Documentation, validation, verification, cybersecurity, and IEC 62304 compliance support for SaMD.
Learn MoreTechnology
We specialize in providing comprehensive solutions tailored to meet the unique needs of the medical and IVD device industry
Our Products
GAPSmart AI
An intelligent regulatory compliance assistant, currently in development, built to automate MDD-to-MDR and IVDD-to-IVDR transitions and ISO GAP assessments.
Learn MoreMedoQi IntelliVigilance™
An AI-powered platform for complaints handling, vigilance reporting, and post-market surveillance for medical devices and IVDs.
Learn MoreMedoQi ClaimXpert Suite
An AI-powered platform for medical coding automation and revenue cycle management for healthcare organizations.
Learn MoreHoodin
A regulatory intelligence platform helping life sciences companies manage global regulations and market surveillance.
Learn MoreBSI Compliance Navigator
A digital platform from the British Standards Institution providing centralized access to standards, regulations, and guidance documents.
Learn MoreExtended 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
CTODriving Tech Innovation as Co-founder & CTO | Building AI Platforms to Solve Complex Challenges in MedTech and Gaming
Martin King
Senior 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)Frequently Asked Questions
Answers to common questions about medical device and IVD regulatory compliance consulting.
What is medical device regulatory compliance consulting?
Medical device regulatory compliance consulting helps manufacturers meet the legal and quality requirements needed to design, test, and market medical devices in a given country or region.
What is Software as a Medical Device (SaMD)?
SaMD refers to software intended for one or more medical purposes that performs these purposes without being part of a hardware medical device.
Contact Us – 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
Bengaluru
Siddapura, Whitefield, Bengaluru, 560066 Karnataka, India