Global Regulatory Services
End-to-end compliance and certification solutions for international market expansion.
End-to-end compliance and certification solutions for international market expansion.
At QM Service Global, we do not just prepare paperwork; we engineer sustainable quality systems. Backed by the technical legacy of Quality Management Services India, our experts bridge the gap between your innovative products and the world’s most stringent regulatory bodies.
Implementation and audit support for ISO 9001, 13485 (Medical), 27001, 14001, and 45001. Elevate operational excellence and build global trust.
Compliant entry into the US market. We manage Establishment Registration, Device Listing, 510(k) submissions, and act as your official US Agent.
Mandatory access to the European Economic Area. Expert guidance on MDR 2017/745, IVDR compliance, and comprehensive Technical Documentation.
Secure your post-Brexit market position. We provide full UKCA strategy, MHRA registration, and UK Responsible Person (UKRP) representation.
Capture the booming Indian market with our local expertise. Seamless CDSCO medical device registration and BIS product certification.
Expand effortlessly with EU Authorized Representative (EC REP) services, Saudi SFDA registration, and SEDEX/SMETA ethical compliance audits.
Speak with our lead auditors today to map out your global expansion strategy.