Let's Get To Know Each Other
Welcome to MedQ Compliance — Your Guide to Medtech Regulatory Excellence. Expert Consulting for Quality Assurance and Regulatory Approvals.
Kallol Sen
Founder & Director
Kallol has deep and broad experience in the quality management system and global regulatory requirements of medical devices including invitro diagnostics, AI/ML-based SaMD and Digital Health solutions. Throughout his career, he has supported multiple medical device, IVD and SaMD companies to surpass the regulatory challenges in US, EU, India, ASEAN and other international markets.
During his professional career, Kallol has developed expertise in various regulatory guidances and standards such as ISO 13485, 21 CFR Part 820, ISO 14971, IEC 62304, IEC 62366, ISO 15197, ISO 15223, ISO 20417, IEC 60601, EU MDR/IVDR, MDCG and Indian Medical Device Regulations.
With his strong educational background with a Master’s in Biotechnology & Post Graduate Diploma in Clinical Research & Data Management, Kallol has developed his passion for medical devices at an early stage of his career. He is also a certified ISO 13485 Lead Auditor and Six Sigma Green Belt. He has handled leading positions in the QA & RA department of multiple MedTech startups.
Mission
To empower our clients with the knowledge, strategy, and support they need to navigate the intricate regulatory pathways and achieve global market success. We are driven by a passion for innovation, patient safety, and the advancement of healthcare worldwide.
Vision
To build a quality culture within your core team and create a strong QMS and regulatory strategy that will help you to strive through global market approvals and achieve regulatory compliance.
Open for Appointments
Our team is ready to assist you on your compliance journey.
Mission
To empower our clients with the knowledge, strategy, and support they need to navigate the intricate regulatory pathways and achieve global market success. We are driven by a passion for innovation, patient safety, and the advancement of healthcare worldwide.
Vision
To build a quality culture within your core team and create a strong QMS and regulatory strategy that will help you to strive through global market approvals and achieve regulatory compliance.
Excellence for by
Our team member ensures precise guidance, fostering regulatory success and client satisfaction in the dynamic Medtech landscape.
Manoj Kumar
Executive Manager
Divya Ram
Compliance Lawyer