Legal analysis: Changes in technology include: changes in production flow, changes in machinery and equipment, changes in processing methods, changes in auxiliary materials used in the process, and changes in tools used in each stage of the process. One party to the other party to be transferred to the cost of proprietary technology. Intangible technology assets are divided into know-how and patents, and patents are stronger than know-how in terms of legal protection. Know-how needs to be kept secret by the owner and can be transferred.
Legal basis: "process and equipment change management specification"
The second This specification is the basic guidelines for the production of medical devices quality management system, applicable to the design and development of medical devices, production, sales and service of the whole process.
Article 3 The manufacturer (hereinafter referred to as the manufacturer) shall, according to the characteristics of the product, establish a quality management system in accordance with the requirements of this specification, and maintain effective operation. As a component of the quality management system, the production enterprise shall implement risk management in the whole process of product realization.
Chapter II Management
Article 4 The production company should establish the appropriate organizational structure, the responsibilities of each agency, authority, clear quality management functions. Production management and quality management department shall not be responsible for each other.
Article 5 The person in charge of the production enterprise shall have and perform the following duties:
(1) organization to develop the quality policy and quality objectives of the production enterprise;
(2) organization to plan and determine the realization of the product process to ensure that it meets the customer's requirements;
(3) to ensure that the quality management system for the effective operation of the necessary human resources, infrastructure and working environment
(d) organization and implementation of management review and keep records;
(e) designate people and departments responsible for the collection of relevant laws and regulations, to ensure that the corresponding laws and regulations in the production enterprise internal implementation.