International Scientific Journals
of Scientific Technical Union of Mechanical Engineering "Industry 4.0"

Manufacturing of medical products is a very wide market. Many steps must be taken to ensure that produced product is sterile and safe and efficient to use for the customer. All manufacturing system from production floor to the type of sterilization must comply with required standards and regulatory. Every step of introducing new product to the production to routine production itself must be well documented and justified to be able to release the product to the market for human consumption. This paper presents information of production area requirements for medical devices, sterilization methods and sterilization indicators, briefly overlooks the q uality control of such processes and the effectiveness of it.