Six Sigma

Mike has extensive knowledge of the Medical Device Sector and its associated requirements. The validation and quality systems expertise delivered during our product development and launch activities was of major benefit in meeting our objectives. The expertise provided and direction given also facilitated existing and future development programs within the organisation.

Mike Heavey was commissioned to compile a Technical File for some Products manufactured by VistaMed, which was completed on time and on budget. The quality of the work was completely satisfactory, with minimum supervision or disruption to other staff. Mike demonstrated an excellent knowledge of Quality Systems required for the Medical Industry and was very competent and efficient.

The six sigma expertise and advanced statistical tools utilised during the program launch activities was of major benefit in meeting our requirements and the requirements of our customer. Validation expertise provided and direction given on validation execution delivered enabled the establishment of best-practices for future development and technology transfer programs.

Regulatory compliance expertise delivered during the initial start-up activities was of major benefit in meeting our requirements and the requirements of our customer. Quality System and Product Certification expertise provided enabled the delivery of future customer requirements. Experience in the field of QA, expertise and training in Six Sigma and hands on approach to Project Management and Implementation has proved to be an invaluable consulting asset to Clada Medical Devices. Knowledge in a… Read more

The program management, validation, statistical expertise and leadership delivered during our Drug Eluting Stent product development and launch activities was of major importance in meeting our objectives.