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Successful implementation of PDM products in the medical device industry
Background of the project
A medical device company in Suzhou is a German-based medical device company. MAQUET is a medical equipment and systems engineering company with a history of more than 170 years. It is part of the Swedish GETINGE AB Group. The group consists of the Department of Surgery Systems, the Department of Cardiac Surgery, and the Department of Critical Care. All brands under the jurisdiction are industry leaders. As one of the world's largest providers of operating theatres, ICU medical engineering and equipment, MAQUET is committed to improving the quality, effectiveness and workflow of medical treatments, providing the highest quality systems engineering for operating rooms, cardiothoracic surgery, and ICUs worldwide. Series products. In the process of product development, Maikewei Suzhou Company has infused the concept of pursuing high quality and high reputation, and strives to meet the requirements of customers 100%. In order to better improve design efficiency, achieve engineering collaboration, monitor R&D quality, track historical issues, and manage all aspects of quality control processes. After detailed requirements research and comparison, Mai Ke Wei selected DSM's PLM SMARTEAM products as its product data management platform.
■ Design drawings and design files to find difficult version control
■ CATIA model management is difficult, the management of the drawing number and material number is confusing, and the relationship is unclear.
■ Manual management is difficult to ensure the accuracy of design documents, and it is easy to cause inconsistency between electronic documents and paper documents.
■ The relationship between products is complicated, and it is difficult to manage the version of borrowed drawings.
■ There is no record of browsing and copying the design file, which is easy to cause technical leakage.
■ Complex business processes, numerous coordination departments, difficult information feedback, and low efficiency among departments
■ Design and review process is not recorded, it is difficult to carry out process traceability and project monitoring
■ In the quality assurance process, you need to sign up to 10 places, each person has multiple signatures, and the offline paper process cannot be tracked.
■ Document query needs to be queried by the DCC (Document Management Center) management office. If you search for it, it can't be used as a reference for the final or valid version.
■ Tasks that deal with problems such as non-conformance processes (multitasking) cannot be tracked, and can only be confirmed by calling each person continuously.
■ For the security of electronic documents, the system must also meet the requirements for system certification in the US FDA certification for the medical device industry.
■ There is currently no valid platform for document issuance.
■ The flow of business personnel is fast, resulting in the loss of design experience.
Through the implementation of the 7-month SMARTEAM project, the RD department around Michael's company completely solved the user's document management, CATIA data integration management, CAPA process management, NCR process management, DCR process management, and ControlChange process. Class data coding management, R&D project management, etc. During the implementation of the entire project, the specific concerns of the company are:
Seamless integration of office automation
1. Achieve seamless integration with Word and Excel.
2. Realize bidirectional mapping of various document contents and PDM attributes.
3. More in line with business processes and strengthen collaborative work.
4. And can realize the electronic signature of the document.
1. Realize the overall management of the final document and establish the Mai Ke Wei Electronic Document Control Center.
2. Automate archiving and combine with various electronic processes.
3. Realize the statistical report of the data after archiving.
Electronic signature and electronic stamp
1. In the electronic process, the electronic signature of the node is audited and multi-person signature is supported.
2. Validation measures for the validity of electronic signatures.
3. Handwritten signature and signature date are automatically generated in various documents (Word type, Excel type, CATIA drawing type).
Control of various quality assurance processes
1. Process customization, each process node pops up a form according to the process requirements, and fills in.
2. According to the different roles accessed by the process node, the permission control of the fillable content is implemented.
3. Once the process object is established, the corresponding process object form is automatically mounted.
4. Implement the mapping between the process object and the process object form important information.
5. In the process of implementing the process, the distribution of each task under the main process.
CATIA data integration management
Property management tool
2. Two-dimensional map template and two-way mapping
3. 3D->2D attribute mapping
4. Create a part number based on the rules
5. Automatically create a BOM table
6. Handwritten signature printing
Through the implementation of this project, the business unit of Mai Ke Wei Company has obtained the following benefits:
1. Reduce product design costs and get products to market quickly.
2. Significantly shorten the product development cycle through design reuse.
3. Product optimization, quality control
4. Accelerate business collaboration through electronic workflow
5. Retroactive and FDA-approved