Regulatory Affairs

We, at SRAMS MedTech Solutions, offer comprehensive regulatory affairs solutions for Medical Technologies, Healthcare and Automotive industries to meet global regulatory compliance efficiently. Our end-to-end services cover regulatory strategy, identification, evaluation, technical writing, technical document, submissions, product approval and post-market compliance — ensuring products reach international markets including, Europe, US, LATAM, ASEAN, CEMA smoothly and sustain regulatory approval throughout their lifecycle.

Medical Devices:

End to End Regulatory Functions.
Medical Device Classification and Strategized Regulatory Submission Pathways
Technical Document / Medical Device File
Comprehensive Gap Assessment and Remediation
Design Documents (DHF)
Risk Management File
Labeling
Technical Writing
Authorized Representative/Importer/Distributor
Mapping of Applicable International/Country Specific Standards.
Support in testing Performance, Safety, EMC, SaMD, SiMD testing, Biocompatibility, Sterilization, Stability and Packaging Validation.
Deficiency and Non-Conformance Response Management
Regulatory Intelligence, Change Notification and Lifecycle Management
Design or Manufacturing Changes Impacting Compliance

In-Vitro Diagnostics:

Strategized Regulatory Submission Pathways for IVD listing
Country-Specific Regulatory Mapping and Strategic Documentation Planning
Technical Document / IVD Dossier
Analyte Characterization
Facility Listing, MDUFA Fee
Performance Evaluation Plan (PEP), Performance Evaluation Report (PER),
Scientific Validity (SVR), Analytical and Clinical Performance (APR&CPR).
Design and Development Files
Biological Evaluation Documents
Labeling
Authorized Representative
Accredited Laboratories for Analytical Performance, Clinical Validation, Stability, Software, Packaging, and Sterilization Testing
Deficiency and Query Response Management
Support for Design, Analyte, or Manufacturing Changes Impacting Regulatory Conformity.