Elexes Team 
Achieving and Sustaining Class IIb Compliance for a Medical Software Device
A Class IIb medical device software manufacturer achieved CE marking under EU MDR with Elexes' regulatory and quality support. The engagement included clinical evaluation report preparation and updates, IEC 62304 software lifecycle compliance, ISO 13485 quality management, software change control, and ongoing notified body assessment support.
Strengthening Software Lifecycle Compliance for a Connected Diagnostic Device
A connected point-of-care hemoglobin measurement system achieved Class B IVD CE marking under EU IVDR. Elexes supported the manufacturer through IEC 62304 software lifecycle documentation, software verification and validation, cybersecurity and risk management documentation, and TÜV assessment support.
Structured RFI Compliance & Information Security Alignment for a Biospecimen Provider
A medical device company responding to a Request for Information (RFI) required alignment between regulatory documentation and information security expectations. A gap assessment and documentation review were conducted to organize compliance evidence. The process improved response clarity, strengthened internal controls, and supported consistent regulatory and information security compliance.
FDA Inspection Advisory and Risk Management File Review for a Class II Medical Device Manufacturer
A Class II medical device manufacturer received targeted FDA inspection advisory support, including risk management file review, identification of gaps against FDA QSR and ISO 14971, and corrective action guidance. The engagement strengthened documentation, improved inspection readiness, and reduced regulatory risk.
Strategic Regulatory Due Diligence for a Hair & Follicle Monitoring Platform
A digital health company pursued Health Canada approval for a hair follicle monitoring platform. The engagement involved regulatory pathway assessment, compliance gap analysis, risk evaluation, documentation review, and tailored Health Canada strategy planning.
Regulatory Readiness Support for a Class IIa Therapeutic Medical Device
A Class IIa therapeutic medical device achieved TGA regulatory readiness through evidence planning, gap analysis, conformity assessment preparation, risk management, documentation refinement, and strategic support to meet Australian regulatory requirements.
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.
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.
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.
