Meet Facility Coordinator and Quality Manager, Michael Parlas.
What is your role?
I wear two hats at the Translational Research Initiative for Cell Engineering and Printing (TRICEP). This includes both Facility Coordinator and Quality Manager. As the Facility Coordinator, I ensure all projects, infrastructure and equipment are able to run efficiently whilst adhering to WHS requirements. While as the Quality Manager, I provide leadership, guidance and assistance as we implement an ISO13485 Quality Management System, which is instrumental in progressing medical device projects from research to market.
What is your area of expertise and what kind of experience do you have in this area?
I have over five years’ experience working within an ISO13485 environment for both novel and existing medical technologies. This means I have been heavily involved in the product development lifecycle. This includes updates and revisions (both software and engineering) to devices that are already commercially available.
I also have experience in cleanroom operations for sterile product testing, complimenting my Microbiology and Biotechnology educational background. The combination of these skills positions us well for an exciting future at TRICEP whilst we continue to progress along the path of medical device development.
As you have mentioned, you are implementing a QMS System. How is this being executed and how will this system enhance the workings at TRICEP?
The Quality Management System at TRICEP is aligned with ISO13485, the international standard for medical device manufacturers. It is being implemented through developing written procedures and controls over each aspect of not only the projects, but how TRICEP will run as a medical device manufacturer in general.
Through extensive investigations into every detail for each process, we are able to generate a large body of documentation that specifies roles and responsibilities for each task, ranging from top-level policies to project specific operating procedures, as well as extremely detailed instructions for routine work and batch production. This set of documentation and records dictate how projects must be run and imposes strict project controls that enable us to achieve batch-to-batch reproducibility, traceability of all parameters for each process, change control, quality control and testing of all incoming and outgoing products.
The end result is a quality assured environment that is compliant with not only ISO13485, but regulatory bodies across the globe.
How is this work at TRICEP being translated into real applications?
Each project at TRICEP, such as the QMS as well as bioinks and 3D printing, hold their own inherent value, all of which are extremely promising, exciting, and moving through key project milestones as intended.
As a medical device manufacturer, each project exists to provide a solution to a specific industry challenge. All of our projects are being translated into medical devices that have real applications. This is achieved through our rigorous and mandatory testing process as we progress through each stage of the project. We have strict project controls to maintain compliance with regulatory bodies which sees the generation of documentation and extensive record keeping.