Support for history management and standardization of process changes for medical devices.
Optimize the medical device manufacturing process. We support strict version control and the elimination of task dependency.
In the medical device industry, strict change management and traceability in the manufacturing process are required to ensure the safety and effectiveness of products. Particularly from a regulatory compliance perspective, it is essential that the decision-making process and approval procedures during process changes are clearly documented. Inadequacies in records or ambiguities in procedures pose risks that can affect the quality assurance system. Our company supports the visualization and standardization of change management in manufacturing sites and assists in the proper operation of procedure manuals. 【Usage Scenarios】 - Optimization of version management associated with manufacturing process revisions - Documentation and tracking of decision-making processes during process changes - Transfer of technology and skills during personnel changes - Organization of change approval flows within 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 perform tasks accurately - Investigation of causes and sharing of improvement know-how in the event of defects
basic information
【Features】 - Visualization of business flow for design and work changes - Organization of reasons for changes, decision criteria, and approval procedures - Support for work standardization and manual development - Establishment of a system for sharing know-how on defect response and improvements - Transmission of technology and skills, and measures against dependency 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
【First Online Consultation: Free】 We offer a free consultation for about 30 minutes regarding change history management in manufacturing, business visualization, work standardization, and the transmission of technology and skills. If you wish for specific improvement support or consulting, we will provide a customized estimate based on the relevant business and scope of support.
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Model number/Brand name
[Free Consultation] Unable to track design and work change history? We support the elimination of dependency on individuals in the manufacturing site!
Applications/Examples of results
【Recommended for those in the manufacturing industry with the following concerns】 ■ Management of design changes Unable to determine "who changed, 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 criteria for judgment vary by person in charge, leading to a growing reliance on individual employees. ■ Quality control and defect response Past causes of defects and improvement histories are not shared, resulting in the same issues recurring. ■ Transmission of technology and skills The experiences and know-how of veteran employees are not adequately documented, raising concerns about handovers after retirement or transfers. ■ Business improvement and DX promotion 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 first.
Line up（4）
| Model number | overview |
|---|---|
| Free consultation for the manufacturing industry | 30-minute online consultation on change management, business visualization, and standardization. |
| Change management process visualization support | Organize the reasons for changes and approval procedures to support business improvement. |
| Support for standardizing work procedures and developing manuals. | Support for standardizing work procedures and eliminating dependency on individuals. |
| Support for the inheritance of technology and skills | Visualizing the know-how and judgment criteria of veteran employees. |
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![[Free Consultation] Is quality unstable even with standard operating procedures? Measures against personnel dependency and work variation in the manufacturing site.](https://image.mono.ipros.com/public/news/image/1/2116324/IPROS10385353290531544663.png?w=280&h=280)
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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.