Purpose and goal
Profundus is developing a camera to take high-resolution images of the fundus/retina, and is now preparing for commercialization and industrialization. The product will be produced in its own facilities. To meet legal requirements, as well as ensure efficient and controlled manufacturing that results in high-quality products, Profundus will create processes throughout the Operations chain, including control of suppliers, purchasing, traceability and manufacturing.
Expected effects and result
The expected result is issued and approved processes, instructions and templates to ensure complete control of the entire ´operations chain´. Another expected results is the training of relevant personnel. Issued governing documents and trained personnel will lead to Profundus having complete control of the Operations area and ensuring efficient and controlled manufacturing resulting in high quality products that meet all applicable legal requirements.
Planned approach and implementation
The work involves issuing processes, instructions and templates to ensure complete control of manufacturing, documentation and traceability. This work requires that all elements are reviewed in detail to ensure complete coverage of all elements. Once the governing documentation is produced, training of the relevant personnel will be planned. The planned structure and implementation will ensure competence building of the project manager, who is employed by Profundus.
The project description has been provided by the project members themselves and the text has not been looked at by our editors.
