Quality assurance

Our customers rely on our established standards to manufacture safe and effective products of the highest quality.

Planet International and its subsidiaries focus on operating under a quality and compliance system to ensure that the highest quality products and services are available to our customers. We are committed to continually improving all aspects of our business and building strong partnerships with our customers and suppliers.

Planet (Suzhou) Medical Product Co., Ltd has passed the audit based on the standards of different types of medical device industries and obtained the qualification to produce sterile medical device. We have also obtained a medical device manufacturing license and hold multiple registered products, and have more than 140 sets of various manufacturing machine and test equipment.

Regulatory affairs

Regulatory affairs

Planet (Suzhou) Medical Product Co., Ltd is in compliance with FDA's Quality System Requirements (QSR), current Good Manufacturing Practices (cGMP)

and other regulations in the countries where we sell our products.

Planet (Suzhou) Medical Product Co., Ltd has passed the certification and meets the quality management requirements of the International Organization for Standardization (ISO).

ISO certification means that the quality management system has been thoroughly reviewed by the external audit committee and meets strict standards.

BSCI Certificate
FDA REGISTRATION
MDD 93/42 EEC DIRECTIVE
ISO 13485:2003 CERTIFICATE