Support for history management and standardization of design changes for medical devices.
[Free Consultation] Unable to track design and work change history? We support the elimination of dependency on individuals in the manufacturing site!
Optimize design changes in medical device manufacturing. Support the visualization of change history and the standardization of operations.
In the medical device industry, accurate record-keeping and version management of design changes and work changes are required based on strict quality control standards. Particularly, when the decision-making process and approval procedures for changes are unclear, there is a risk of impacting the quality assurance system. Our company supports the visualization and standardization of change management in manufacturing and design environments and assists in the proper operation of procedural documents. 【Usage Scenarios】 - Optimization of version management associated with design changes - Recording and tracking of the decision-making process during design changes - Transfer of technical skills and knowledge during personnel changes - Organization of change approval flows in the quality control department 【Benefits of Implementation】 - Improved reliability of quality management through clarification of change history - Elimination of dependency on specific individuals, creating an environment where anyone can work accurately - Investigation of causes and sharing of improvement know-how in the event of defects
Inquire About This Product
basic information
【Features】 - Visualization of business flow for design and work changes - Organization of reasons for changes, judgment criteria, and approval procedures - Support for work standardization and manual development - Establishment of a system for sharing know-how on defect response and improvements - Measures for technical and skill inheritance and reducing dependence on individuals 【Our Strengths】 Through the business ecosystem 'exbridge', we collaborate with experts well-versed in solving challenges in the manufacturing industry. We propose optimal improvement measures tailored to your on-site conditions and support sustainable business standardization.
Price information
【Initial Online Consultation: Free】 We offer approximately 30 minutes of free consultation regarding change history management in manufacturing, business visualization, work standardization, and the transmission of technology and skills. If you are looking for specific improvement support or consulting, we will provide a customized estimate based on the relevant business and scope of support.
Delivery Time
※The schedule for free online consultations will be adjusted individually based on your preferences. The specific start date and duration of the improvement support will be determined in consultation according to the content of the support.
Applications/Examples of results
【Recommended for those in the manufacturing industry with the following concerns】 ■ Management of design changes Unable to determine "who changed it, when, and why," making it difficult to track the reasons for changes and the approval process. ■ Standardization of operations on the manufacturing floor Work procedures and decision-making criteria vary by individual, leading to a reliance on specific personnel. ■ Quality control and defect response Past causes of defects and improvement histories are not shared, resulting in the same issues recurring. ■ Transfer of technology and skills Experience and know-how of veteran employees are not adequately documented, raising concerns about handovers after retirement or transfers. ■ Business improvement and promotion of digital transformation (DX) Wanting to review business flows and management rules but unsure where to start. 【Examples of utilizing free consultations】 Organizing current issues, discussing improvement themes, and exchanging information on how to visualize and standardize operations. Please feel free to consult with us.
Line up(4)
| Model number | overview |
|---|---|
| Free consultation for the manufacturing industry | 30-minute online consultation on change management, business visualization, and standardization. |
| Support for visualizing change management processes | Organize the reasons for changes and approval procedures to support business improvement. |
| Support for standardization of work processes and development of manuals. | Support for standardizing work procedures and eliminating dependency on individuals. |
| Support for the Transmission of Technology and Skills | Visualizing the know-how and judgment criteria of veteran employees. |
catalog(36)
Download All Catalogs
News about this product(1)
Company information
Optimal solutions for solving management challenges! A company that provides network business aimed at a business ecosystem. Together with the most suitable experts tailored to your management and on-site issues, we realize problem-solving. Developing a face-to-face platform business called 'exbridge' for the business ecosystem. We build a business network to support problem-solving in relation to the issues and management challenges faced by companies, in collaboration with specialized solution partners. We provide services through networks aimed at sustainable growth. Planning and managing seminars and events for building a business ecosystem.



![[Free Consultation] Support for design and work change history management and business standardization!](https://image.mono.ipros.com/public/product/image/2116324/IPROS15314556921291784503.png?w=280&h=280)
![Support for standardization of manufacturing processes and improvement of quality variation [Free consultation]](https://image.mono.ipros.com/public/product/image/2116324/IPROS3598932027335189301.png?w=280&h=280)