Team Elexes 
End-to-End TGA Approval for a Therapeutic Nebulizer Device
A medical device company successfully obtained TGA approval for a therapeutic nebulizer. The project involved regulatory pathway planning, conformity assessment, clinical evaluation, implementing ISO 13485, and establishing post-market surveillance.
FDA Pre-Submission & Clearance Support for an Oxygen-Delivery and Respiratory Training System
A medical technology company successfully secured FDA pre-submission clearance for an oxygen delivery and respiratory training system. The project encompassed aligning clinical data, conducting risk testing, developing an FDA strategy, and preparing a comprehensive regulatory submission.
End-to-End 510(k) Clearance for Imaging Based SaMD Device
A medical technology firm successfully achieved 510(k) clearance for an imaging-based SaMD that analyzes X-rays to detect respiratory diseases. The project involved aligning clinical data, conducting risk testing, developing an FDA strategy, and preparing a comprehensive regulatory submission.
Accelerated 510(k) Clearance for Hemodialysis-Related Class II Device with Robust Microbial Safeguards
510(k) clearance was achieved for a hemodialysis device through comprehensive risk assessments, verification of design modifications, and adherence to FDA regulatory requirements, ensuring full compliance, market readiness, and patient safety.
Elexes | SaMD Regulatory Support Snapshot
Regulatory support was provided for multiple Class II SaMD projects, including a cognitive support tool, remote monitoring app, and AI-based ECG system. Work included strategy, pre-submission prep, 510(k) planning, clinical evaluation, cybersecurity, and risk management per ISO 14971/IEC 62304, achieving a 100% 510(k) success rate in 36 months.
Guiding a Cardiac CDSS to Market Success with Elexes
Comprehensive regulatory support was provided for a cardiac Clinical Decision Support System (CDSS) to successfully obtain FDA 510(k) clearance. The scope of work included regulatory strategy development, pre-submission interactions with the FDA, 510(k) submission planning, clinical evaluation, cybersecurity compliance, and risk management in accordance with ISO 14971 and IEC 62304 standards.
Innovative Journey Accelerating FDA Clearance for Next-Gen Blood Glucose Monitoring Device
Achieved expedited FDA 510(k) clearance for a next-generation blood glucose monitoring device through a robust regulatory strategy, full ISO 13485 compliance, and comprehensive risk management.
Navigating MDSAP For Harmonized Regulatory Compliance
A medical device company successfully navigated the Medical Device Single Audit Program (MDSAP), achieving faster global market access by aligning its quality management system with ISO 13485 and meeting regional regulatory requirements.
