Скачать с ютуб How to Improve Design Control Workflow in Medical Device Manufacturing в хорошем качестве

How to Improve Design Control Workflow in Medical Device Manufacturing

Click here to watch the full webinar for free: https://xtalks.com/webinars/how-to-im... The purpose of design control is to establish methodologies and processes for the development of medical devices. The goal of these development processes is to ensure that the device meets its intended use, it meets user needs and it adheres to safety requirements. Along with risk management, it is critical for a medical device manufacturer to have established and efficient design control processes from the beginning of product development. The typical industry practice is to design and print: create the design and then print to paper and store that document in a binder. Very often, the documents are printed, scanned and stored both electronically in file folder structures as well as in physical binders. Another common practice is to make extensive use of spreadsheets to keep track of user needs, design inputs and outputs, verification and validation plans and results. These common practices are manual processes which are very labor-intensive and time-consuming. But more importantly, these processes are also error-prone. Even if the product meets its intended use, having records that are incomplete or stored in a wrong version puts the medical device product at risk. Many medical device companies are still exposed to a high degree of risk when it comes to their design control processes. Software solutions have claimed to help the industry to come to grips with these challenges and provide a complete solution, yet there remain gaps that have yet to be filled. As a result, the industry is fraught with manual processes, underground systems and undocumented procedures. In this free webinar, the featured speakers will describe a comprehensive solution which minimizes these gaps and targets the challenges that face medical device companies every single day.