Compliance with medical device development! Introduction to essential information and related services you should know.
Regarding compliance in medical device development, while I will not touch on the details of the standards, I would like to introduce some basic information about CSV and ER/ES that you should know as a person in charge of PLM implementation. CSV defines the documentation of the validity of the system development process and the results of verification, and addresses requirements based on the ER/ES guidelines. We will support the establishment of the management and operational framework necessary for the application of the PLM system. 【Requirements for PLM System Application】 ■ Access rights management ■ Acquisition of operation logs ■ Robust backup ■ User and password management ■ Update records ■ Training and education *For more details, please download the PDF or feel free to contact us.
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【Related Services】 ■ PLM Quick Assessment ■ PLM Concept Planning Service ■ PLM Requirements Definition Service *For more details, please download the PDF or feel free to contact us.
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【Purpose】 ■Development and production of pharmaceuticals and medical devices ■Application of PLM systems used in medical device development *For more details, please download the PDF or feel free to contact us.
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We are developing a business specialized in PLM, and for that reason, we have adopted "Product Lifecycle Management" as our company name. In order to provide comprehensive solutions, we have a strong consulting capability that addresses PLM business issues from a managerial perspective, as well as highly valuable support services from a technical standpoint, allowing us to confidently say, "Leave it to us." Our team consists of experts, particularly in the area of PDM (Product Data Management), where we have extensive experience and a proven track record over many years. Therefore, we take pride in being able to offer our customers greater "satisfaction" through the know-how accumulated in both business and system aspects during the construction process, as well as through prototyping. PLM Japan aims to be the No. 1 solution innovator in Japan across the entire engineering field, driven by a professional group that continuously challenges itself and strives for improvement.
