2024年6月7日发(作者：)

epc 设计控制措施

英文回答：

Engineering and Production Change (EPC) Design Control

Measures.

EPC design control measures are an essential part of

ensuring product quality and patient safety in the medical

device industry. By implementing effective EPC design

controls, manufacturers can minimize the risk of errors and

defects, and ensure that their products meet the highest

standards of performance and safety.

Key EPC Design Control Measures.

The following are some of the key EPC design control

measures that manufacturers should consider:

Design review and verification: A systematic and

independent review of the design to ensure that it meets

the requirements of the product specification and that it

has been properly implemented.

Design validation: A process to demonstrate that the

design meets the user needs and intended use of the product.

Design transfer: A process to transfer the design from

the design team to the manufacturing team, ensuring that

all design information is accurately and completely

transferred.

Design change control: A process to control and manage

changes to the design, ensuring that all changes are made

in a controlled and documented manner.

Design history file: A record of all design activities,

including changes, that provides a complete history of the

design.

Benefits of Effective EPC Design Controls.

Effective EPC design controls can provide the following