Process technology change management

Legal analysis: technological changes include: changes in production technology, changes in machinery and equipment, changes in processing methods, changes in auxiliary materials during the process, and changes in tools used in each process. Fees paid by one party to transfer know-how to another party. Intangible technical assets can be divided into proprietary technology and patents, and patents are more protected by law. Proprietary technology needs the owner's own confidentiality and can be transferred.

Legal basis: management specification for process and equipment change.

Article 2 This Code is the basic guideline for the quality management system of medical device production, which is applicable to the whole process of medical device design, development, production, sales and service.

Article 3 A production enterprise (hereinafter referred to as a production enterprise) shall establish a quality management system according to the product characteristics and the requirements of this specification, and keep its effective operation. As an integral part of quality management system, production enterprises should implement risk management in the whole process of product realization.

Chapter II Management Responsibilities

Article 4 A production enterprise shall establish a corresponding organizational structure, clarify the responsibilities and authority of each organization, and clarify the quality management functions. The person in charge of the production management department and the quality management department shall not concurrently hold positions with each other.

Article 5 The person in charge of a production enterprise shall have and perform the following duties:

(a) to organize the formulation of quality policies and quality objectives of production enterprises;

(2) Organize, plan and determine the product realization process to ensure that customer requirements are met;

(3) Human resources, infrastructure and working environment needed to ensure the effective operation of the quality management system;

(4) Organizing the implementation of management review and keeping records;

(5) Designate special persons and departments to be responsible for the collection of relevant laws and regulations, and ensure that the corresponding laws and regulations are implemented within the production enterprise.