QA&C Consulting™ was established in Australia to leverage over 20 years of my professional experience in Quality Assurance and Quality Control management across multiple highly regulated industries, including medical device design and manufacturing, rail, and mining. With a results-driven approach grounded in real-world business experience, I prioritise efficiency and effectiveness, wasting no time on idle conversations or over-utilising valuable resources, focusing exclusively on delivering fully compliant, functional, and customised Quality Management Systems specifically tailored to each client’s operational requirements at competitive and sustainable rates. Holding multiple internationally recognised certifications and professional qualifications, I currently provide specialised consulting services primarily to medical device manufacturers in the following areas:
Auditing established QMS (CQA) for ISO 9001 compliance
Building QMS from ground up for small businesses and start ups
Risk Management Framework ISO 31000, ISO 14971
Medical device SW development IEC 62304
Production part approval process (PPAP)
Supplier Audit Management Framework
Verification and Validation (V&V) to FDA requirements
Product Development Framework for medical device class 1,2,3
Manufacturing to ISO 13485 requirements
Change Management
Project Management
About QA&C Consulting
Medical Device QA and Regulatory Consulting expertise
My name is Dimitri Leo. With over 20 years of professional experience dedicated to Quality Management, I saw a recurring pattern across companies of all sizes: Quality Assurance was often treated as an afterthought. It was reactive, under-resourced, and misaligned with the development lifecycle. With decades of hands-on experience in QA strategy, and leading quality teams, I knew there had to be a better way.
That’s why I founded QA&C Consulting™, to help organisations overcome QA challenges in a ptactical, swift and affordable way. My mission is to shift QA from being a bottleneck to becoming a strategic enabler of quality, speed, and confidence. With a Master’s degree in Engineering and a PhD background, I bring a strong academic foundation to my work, complemented by certifications as a Quality Auditor and Project Manager, which enables me to navigate both the technical intricacies and the broader operational demands of quality-driven industries. Throughout my career, I’ve contributed across a wide range of sectors including civil aviation, RF and GPS navigation systems, IT, mining, and most extensively medical devices design and manufacturing. In these fields, I have led cross-functional engineering and quality initiatives, driving product design and development, manufacturing, QA/QC and regulatory compliance.
Founder Story
