2.1. QMS Processes Established procedures, policies, and controls that ensure the consistent quality of the medical device throughout its development, manufacturing and post-market. [dsm_advanced_tabs dsm_tabs_bg_color="rgba(255,255,255,0.3)"...
Interactive Guide 2 – 2
2.2. Supplier Management The process for the evaluation, selection and re-evaluation of suppliers providing completed devices, components, materials, accessory devices, and global cloud services to ensure all the products and services meet the...
Interactive Guide 2 – 3
2.3. Environment Control (Manufacturing, Storage) The controlled conditions, such as temperature, humidity, cleanliness, accessibility and layout, required for the production and storage of the medical device and its components to meet the specified design and...
Interactive Guide 2 – 4
2.4. Manufacturing Processes The documented procedures, equipment, and methods used to produce the medical device in a consistent and controlled manner, ensuring the final product meets the design specifications and regulatory requirements.[dsm_advanced_tabs...
Interactive Guide 2 – 5
2.5. Product Specifications The product specifications are the formal design inputs and as such must contain the information about the product, material characteristics, packaging characteristics, required functional, performance, reliability, usability, labeling,...