Providing Quality and Regulatory Affairs Solutions aligned with and supporting Business Growth! Developed Successful Solutions focused on Understanding Business and Operational Needs, while efficiently and effectively managing risks, enabling Long Term Business Growth. Our clients include multinational Medical Device and In-Vitro Diagnostics Corporations worldwide.Services:"Hands-On" Targeted Quality System Assessments (or audits) to determine gaps where opportunities exist for improvement in effectiveness of processes including Design Control, CAPA, Manufacturing processes, Supply Chain, Risk Management and process efficiency for Class I, II and III devices;Product registration/licensing support and execution;Regulatory Audit preparation assistance and guidance;Support and advice for Regulatory Authority (Notified Body and other Agencies') contacts/meetings;Project Management - Developing and implementation of new Quality Systems, improvement and/or remediation plans.Training in Quality Systems implementation ISO 13485 (including US Quality SystemRegulation - QSR), Quality System updates, Risk Management ISO 14971, Statistical Process Control; Gauge Repeatability & Reproducibility, Lean, Process Mapping, Total Productive Maintenance,Process Validation...

Providing Quality and Regulatory Affairs Solutions aligned with and supporting Business Growth! Developed Successful Solutions focused on Understanding Business and Operational Needs, while efficiently and effectively managing risks, enabling Long Term Business Growth. Our clients include multinational Medical Device and In-Vitro Diagnostics Corporations worldwide.Services: "Hands-On" Targeted Quality System Assessments (or audits) to determine gaps where opportunities exist for improvement in effectiveness of processes including Design Control, CAPA, Manufacturing processes, Supply Chain, Risk Management and process efficiency for Class I, II and III devices; Product registration/licensing support and execution; Regulatory Audit preparation assistance and guidance; Support and advice for Regulatory Authority (Notified Body and other Agencies') contacts/meetings; Project Management - Developing and implementation of new Quality Systems, improvement and/or remediation plans.Training in Quality Systems implementation ISO 13485 (including US Quality SystemRegulation - QSR), Quality System updates, Risk Management ISO 14971, Statistical Process Control; Gauge Repeatability & Reproducibility, Lean, Process Mapping, Total Productive Maintenance, Process Validation...

Oriel STAT A MATRIX helps organizations reduce costs and risk by achieving compliance with global regulations and improving business processes. The company’s consultants and trainers provide a full range of RA/QA, Lean Six Sigma, and Performance Improvement training, coaching, and consulting support around the world.

Lead and develop the Philips HealthTech, ASEAN Pacific Quality & Regulatory Affairs Team accelerating Quality and Regulatory process improvement initiatives to better support business growth!

Lead Global Quality and Regulatory Affairs Team to drive quality improvement, manage risk and support business growth!

Director of Regulatory Affairs & Compliance, Greater Asia