Supply Chain Contingency Capability Statement
In accordance with Article 10a of Regulation (EU) 2017/745 on Medical Devices (MDR), Plinma Technology Co., Ltd. hereby declares: ✅ A comprehensive process for the identification and notification of foreseeable supply disruptions has been established; ✅ All currently marketed devices (see [Product List Link]) remain consistently available; ✅ In the event of a planned supply interruption, notifications will be issued to relevant parties at least six months in advance, in strict compliance with regulatory requirements; ✅ Contingency process summary: Summary of Supply Interruption Control Procedure; ✅ Contact: master@plinma.com
《供应链应急能力声明》
根据欧盟医疗器械法规（MDR 2017/745）第10a条要求，本公司声明： ✅ 已建立完善的医疗器械供应中断识别与通知流程； ✅ 当前所有上市产品（详见[产品清单链接]）供应持续稳定； ✅ 若未来发生计划性中断，将严格按法规提前6个月通知相关方。 ✅查看应急流程：《供应中断控制程序》摘要 联络邮箱：master@plinma.com
Sales Service
Product certification
Establish a quality management system in accordance with ISO13485, FDA, and CE related standards, and obtain relevant certificates provided by certification agencies
Implementation standards
In terms of product standards, products have been tested by internationally renowned third-party product testing agencies such as TUV and SGS.
Management system
Use advanced quality management tools, measurement system analysis, Six Sigma, and 5S management to pursue zero-defect products
SERVICE ANNOUNCEMENT
Service Announcement
Thank you for choosing Plinma products. Please read the instructions carefully before using the product. During the after-sales service period of Plinma, if the product has quality problems during normal use according to the requirements of the instruction manual, please contact the sales representative (return procedure), and Plinma will provide free maintenance, inspection and other services according to the situation. If the product does not have quality problems or has exceeded the after-sales service period, paid maintenance and repairs will be provided according to the situation. Additional costs such as freight and inspection fees must be borne by the customer.
After-Sales Service
