Why Choose SRAMS MedTech Solutions?
01.
Partnering with the right Regulatory and Quality expert is the key to accelerating approvals and building a compliant, successful global business.
End-to-End Lifecycle Support;
We provide end-to-end Regulatory and Quality support across globe and the entire lifecycle of Medical Devices, In Vitro Diagnostics, and Pharmaceutical products — from concept to post-market and disposal.
02.
Our Expertise;
Backed by over 18 years of proven experience in Medical Device, In Vitro Diagnostic (IVD), and Pharmaceutical Regulatory Affairs & Quality functions, we specialize in system establishment, regulatory approvals, and post-market activities for global markets.
03.
Proven Track Record;
Successfully filed regulatory submissions across the globe, specializing in navigating complex frameworks such as EU, US, LATAM, CEMA, and ASEAN regulations.
Our expertise extends to the establishment and implementation of Quality Management Systems (QMS) compliant with ISO 13485, MDSAP, QMSR, and other global regulatory requirements — executed with absolute precision.
04.
Technical Standards Expertise
Skilled in applying international standards (ISO, IEC, and other device-specific standards) to ensure compliance and faster approvals
Partner with us to accelerate your market entry with confidence, compliance, and global success