![]() ![]() The value of an adequate design control system includes, but is not limited to, a baseline to review the system at adequate intervals for improvements based on design history, problems, and failures of the design control system. Design control offers improved visibility of the design (development) process to the designers and managers. Design control involves an interrelated set of practices and procedures that are incorporated into the design and development process (i.e., a system of checks and balances). In particular, this seminar will discuss the meaning and scope of Design History File (DHF), Device History Record (DHR), Device Master Record (DMR), and relationship between them in detail.ĭesign control is a subsystem of the quality management systems. This presentation is intended to help you understand and adequately implement Medical Device Design Control for manufacturers and relevant stakeholders. ![]() ![]() Each manufacturer of any class III or class II device, and the some class I devices shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |