MedReg is a medical device regulatory consultancy, founded with one aim in mind – to empower medical device manufacturers by providing regulatory solutions. MedReg has served numerous clients across Europe, the USA, India and the UK. We have supported medical device manufacturers in obtaining approvals, certificates and licences from the relevant authorities, Notified Bodies and certification bodies, such as CE marking, UK MDR, ISO 13485:2016 certification, ICMED, MDSAP, US FDA establishment registration and listing, US FDA 510(k) clearance, PMA, UL certification, CDSCO licences MD-05, MD-06, MD-09, MD-10 and MD-15, Free Sale Certificates and various country registrations.
No matter the size of your business, our team of experts with deep industry knowledge will provide you with the knowledge, guidance, and support to meet the regulatory requirements of your target markets, so you can sell your products in your desired geographic location as fast as possible. We define a regulatory pathway that suits your business and deliver cost-effective strategies for your specific products.
To become a multinational consultancy firm from India, helping clients from India and around the world simplify their journey through ever-evolving regulatory landscapes. We aim to shape the future of healthcare access through strategic insight, collaborative partnerships, and an unwavering focus on global standards.
To empower medical device manufacturers, healthcare innovators, and life science companies to bring their products to global markets with the right regulatory approvals. By delivering expert guidance and end-to-end consultancy throughout the complex regulatory process, we help safe, effective, and innovative medical technologies reach patients.
We are quick learners and constantly adapt to new regulatory rules and developments in the medical industry around the world. With years of experience, our multidisciplinary team brings broad visualisation to every project by understanding the technical requirements and the strategic impact of regulatory decisions and offering a well-rounded approach that combines engineering, clinical, and regulatory expertise. We are committed to adhering to global compliance standards and ethical practices.
Senior specialists who guide every project, from regulatory strategy to quality systems and biological safety.
Biomedical engineers, certified quality auditors and senior regulatory strategists, every one of them specialized in medical devices and IVDs.
At MedReg Consultancy, our strength lies in our collaborative team. We combine biomedical engineering acumen, deep statutory understanding of the Indian Drugs & Cosmetics Act, European MDR regulations, and US FDA 21 CFR guidelines to provide pragmatic, audit-proof solutions.
Unlike generic consultancies, every member of our team is specialized in medical devices and IVDs. From surgical disposables and orthopaedic implants to high-risk Class C and D devices, our specialists work closely with your engineers to translate complex regulatory mandates into clear action items.
Consult With Our Experts
Every project is led by qualified regulatory affairs experts with 5 to 6 years of hands-on experience, supported by junior specialists with 3 to 4 years of experience across our different verticals.
Our experts’ backgrounds
Our numbers tell a story of growth, trust, and proven success. Every result reflects our expertise, commitment, and measurable impact.
Expert consultants, thorough regulatory insight, and a seamless path to compliance, that’s our promise for your medical devices.
Before a single page is drafted, we map your device to the right regulations and find every gap in your files, so your documentation is built once, built right and submission-ready.
We decode Complex regulatory requirements and define a clear, actionable pathway, to ensure your projects move forward efficiently and compliantly.
We dive deep into your requirements, identifying all critical factors to ensure our solutions address every aspect of your regulatory needs.
As experts, we provide clear, accurate, and accessible documentation, keeping you informed at every stage of your project.
MedReg is a regulatory consultancy. Marks are shown to identify the frameworks we support; certificates and approvals are issued by the relevant authorities, Notified Bodies and certification bodies.
CE Mark (EU MDR / IVDR)
CDSCO Central Drugs Standard Control Organisation
MDSAP Medical Device Single Audit Program
ISO 13485:2016 Medical Devices QMS
US FDA 510(k) Premarket NotificationThe people, workplace and moments behind MedReg.
Photo albums from Medical Fair India, Gujarat Medical Expo, MEDICALL and other events are on our Exhibitions page.
