思雨 洪

1.Preparation of technical documents required for the certification of MDR regulations for medical devices, independently completed the preparation of a full set of MDR documents for active/passive/class II/class III medical devices. 2.Guide the completion of relevant audits and corrections; 3.Answer questions about technology, regulations, quality, etc. and provide appropriate consulting services; 4.Provide training services related to MDR regulations.

1.Execute the domestic and foreign product registration tasks, participate in CE, FDA registration document document preparation, responsible for risk management, post-market supervision, product life and other major key document preparation and audit. 2.Participate in the third party audit of TUV, BSI auditing organisations and customers, on-site system audit of new product registration in China, and make corrective replies to the audit opinions in time. 3.Familiar with the domestic registration, CE registration process, can reasonably arrange the product production, verification, three-party testing and other important nodes to do the project progress plan, and production departments, quality departments and external testing organisations in a timely manner to ensure that the progress of product registration. 4.Familiar with domestic and international regulations, tracking related dynamic updates, following up and interpreting the guideline documents issued by MDCG and GHTF, and organising internal staff training. 5.Follow up the product production and post-marketing information, timely collection of customer feedback from the quality department and adverse information of similar products to ensure product safety.