思普

Medical Devices

Requirements Analysis

♦ Compliance documents are fragmented and difficult to audit and trace. Critical compliance documents—such as Design History Files (DHF), Device Master Records (DMR), and design outputs—are scattered across personal computers, shared drives, or multiple systems. The lack of structured relationships and version control makes it difficult to quickly respond to audit requirements from regulatory bodies such as the FDA, CE, or NMPA, resulting in high compliance risks.

♦ The R&D process is disconnected from regulatory requirements. Regulatory requirements such as risk management, usability engineering, and software lifecycle are not effectively integrated into the R&D workflow. Reliance on manual checks and retrospective data entry makes the process prone to missing steps and broken evidence trails, negatively impacting regulatory submissions and market access.

♦ Low cross-disciplinary collaboration efficiency and difficult design integration: Medical, mechanical, electronic, software, and materials teams develop in parallel, but the lack of a unified collaboration platform leads to unsynchronized design changes. This results in frequent issues during later-stage integration testing, high rework rates, and significantly prolonged development cycles.

♦ Engineering change control lacks closure, affecting product consistency. Medical devices are highly sensitive to changes, yet change processes often span multiple departments including R&D, quality, manufacturing, and regulatory affairs. Offline approval workflows are prone to missed execution steps, leading to situations such as "design changed but production unchanged" or "outdated device versions still in circulation," thereby triggering compliance and safety risks.

♦ Knowledge and experience are not transformed into organizational assets, resulting in low innovation and reuse rates. Mature design modules, validation plans, clinical feedback, and corrective actions for adverse events are not systematically captured and stored. This leads to repeated verification and redundant design efforts in new projects, increasing costs and delaying product iteration, making it difficult to establish a platform-based product strategy.

Structural Design Management

Based on the AIAG-VDA FMEA Fifth Edition seven-step methodology, the system provides structured templates, knowledge base-driven recommendations for failure modes, automatic association of prevention and detection controls with design and process elements, and closed-loop risk tracking, enabling seamless integration between DFMEA and PFMEA. FMEA is deeply embedded into the core R&D and manufacturing processes to ensure early risk identification, actionable mitigation measures, and fully traceable outcomes.

Integration with mainstream CAD design software enables seamless connection of design data.
Parallel management of multiple design alternatives，supports simultaneously creating and managing multiple conceptual design schemes within the PLM system, with each scheme independently version-controlled and clearly structured, avoiding scattered files and version confusion.
Professional BOM lifecycle management， bills of materials can be traced back, compared, audited, and renumbered. BOM changes are automatically propagated from design to process engineering, production, procurement, and finance departments, avoiding material obsolescence and production line downtime caused by design changes.
Standardized design and change processes aligned with industry regulations，ensures full compliance and control throughout the product development lifecycle, supporting faster product certification for global market access such as ISO 13485, FDA, and CE.
Enterprise-wide unified coding system,eliminates "one item, multiple codes" or "one code, multiple items," optimizes inventory structure, and reduces capital tied up due to material confusion in transportation and logistics enterprises.
Personalized visual work dashboards,enhance work organization and execution efficiency for R&D personnel in multi-project parallel environments.
Comprehensive standardization solutions, drive enterprises to establish modular design standards, common parts libraries, and design reuse mechanisms, continuously improving component commonality and platform reusability.

Electronic Design Management

SIPM/PLM provides comprehensive support for the entire electronic design process management, deeply integrates with mainstream EDA design tools, and enables bidirectional data integration between schematics, PCB, and the PLM system, ensuring automatic synchronization of design data, unified version control, and managed change processes. The system supports multi-attribute management, intelligent matching, and preferred component selection for electronic parts, combined with enterprise preferred component library strategies, to enhance design quality and supply chain resilience from the outset.

Deep integration with mainstream EDA tools: Automatically extracts BOM information, component lists, and other design data, eliminating manual entry errors and ensuring consistency between design and data.
Differentiated attribute management for electronic components: Supports defining independent attribute templates based on component types (e.g., resistors, capacitors, ICs, connectors), enabling a "one-type-one-template" approach.
Management of alternative and successor components: Structured maintenance of substitution relationships, lifecycle status, and certification equivalency. When primary components face shortages, obsolescence, or supply risks, compliant alternatives ensure continuity in design and production.
Preferred component review during selection: Enables design engineers to initiate preferred-item reviews for candidate components during the selection phase. Based on component preference levels and application scenarios, the system provides prioritized recommendations, guiding engineers toward high-reusability, high-reliability, and cost-effective selections.
End-to-end BOM lifecycle collaboration: Electronic design BOM changes are automatically synchronized to process engineering, manufacturing, procurement, quality, and other departments, enabling full traceability and closed-loop management to prevent incorrect assembly, material obsolescence, or production line stoppages.

Software Development Management

SIPM/PLM is deeply aligned with the intelligent development trends in the medical device industry, effectively managing the entire software development lifecycle from requirements, design, and development to testing and release. Through standardized processes and a modular architecture, it ensures software development complies with industry functional safety and quality standards such as ASPICE and ISO 26262, promoting the accumulation of software assets, module reuse, and agile iteration.

Full lifecycle management of all elements: Comprehensive lifecycle management for all key artifacts—including algorithm documentation, requirement specifications, test cases, and closed-loop bug records—supporting version traceability and compliance auditing.
End-to-end data consistency: Ensures consistency of data flow across all stages, from requirements management and functional design to coding development and software testing.
Seamless integration of end-to-end data flow: Achieves seamless connection between upstream and downstream processes, guaranteeing data consistency throughout requirements management, functional design, coding development, and software testing.
Integrated hardware-software collaboration: Enables comprehensive collaboration between software development, electronic design, and mechanical design, ensuring integrated hardware-software delivery and accelerating the engineering implementation of innovative products.
Agile development support: Supports agile project management methodologies, enabling rapid iteration and responsiveness to evolving customer requirements.

Process Management

SIPM/PLM's process management solution enables integrated management of product design and process planning. It allows seamless viewing of design content and timely transmission of design changes. By collaborating with SIPM/QIS, it automatically receives quality feedback information, ensuring the effective implementation of a comprehensive quality management system. Furthermore, the solution can extend from process management to the management of equipment, fixtures, molds, and NC programs, featuring process model reconstruction capabilities that fully meet the process data requirements of various ERP and MES systems.

Integrated management of product design and process planning,enables seamless viewing of design content and timely transmission of design changes, provides ERP with complete foundational data, and—when integrated with SIPM/QIS—automatically receives in-process quality feedback.
Intelligent, structured, and scalable process solution based on a unified BOM,supports end-to-end data continuity from design to manufacturing, ensuring accuracy and reliability of process documentation.
Supports building a standardized operation library in PLM, covering areas such as injection molding, precision machining, laser welding, and assembly; enables structured description of process symbols to ensure universality and standardization of process documents; and facilitates easy access to resources such as equipment, tooling, and consumables.
Enables rapid process design by reusing standard operations, with direct template-based generation of process cards and work instructions, significantly improving efficiency, reducing repetitive tasks, and shortening process preparation cycles.
Allows enterprises to directly apply the standard process library on the manufacturing BOM for process design, automatically generating process cards to achieve standardized process management, thereby enhancing overall production efficiency and product quality consistency.
Extensible from equipment and tooling to comprehensive management of equipment, tooling, and molds, featuring process model reconstruction capabilities to fully meet the process data requirements of various ERP/MES systems.
Provides the foundation for unified, project-based management of engineering activities, ensuring effective implementation of a complete quality management system.

Project Management

SIPM/PLM deeply integrates requirements from management systems such as ISO 13485 to build a structured R&D management system covering all development stages. With hierarchical project planning and centralized control, R&D project management becomes simple and controllable. Core resources such as design data and technical documents are dynamically assigned based on project tasks, enabling flexible and effective control over data security and sharing. Additionally, multi-dimensional real-time monitoring of ongoing projects is supported, helping managers precisely track project progress, cost, and quality, ensuring high-quality and efficient delivery of R&D projects in environments characterized by high complexity, fast pace, and intense competition.

Hierarchical planning and centralized control of project management make R&D project management simple and controllable.
Supports forward and backward scheduling of project plans; when unexpected changes occur—such as shifts in customer requirements—it dynamically optimizes subsequent paths to minimize impact on the overall project and ensures milestone achievement rates.
Temporarily and precisely allocates access permissions to project documents based on project tasks and collaboration roles, meeting industry security and compliance requirements while enabling efficient data sharing across enterprises and departments.
Enables strong association management between project tasks and deliverables, ensuring that outputs at each R&D stage are complete, traceable, and compliant with industry standards.
Provides multiple visual project monitoring dashboards for real-time visibility into project progress, enabling rapid decision-making and timely intervention.
Supports multi-dimensional performance statistics based on man-hours, task completion rates, and other metrics, providing quantitative data for managers to assign tasks and evaluate employee performance, motivating teams to focus on value-driven delivery.
Real-time aggregation and early warning of project cost items ensure that costs of high-investment R&D projects remain within budget limits.

Personnel Knowledge Management

SIPM/PLM features an integrated performance management mechanism aligned with projects and tasks, along with visualized workload and performance statistics. This enables managers to easily and promptly query the actual workload and performance of personnel across departments by organizational structure. Meanwhile, tailored to the characteristics of the high-tech electronics industry—such as multi-role involvement and strong collaboration—SIPM/PLM provides fine-grained knowledge access control. It supports dynamically assigning temporary permissions based on work requirements, ensuring a high degree of both security and flexibility in access management.

Dual-driven by standardized knowledge base management and project-hour-based performance management, reducing redundant design efforts and inefficient communication.
Features a performance management mechanism deeply integrated with projects and tasks, along with visualized workload and performance statistics. Managers can promptly and conveniently query the actual workload and performance of personnel across departments by organizational structure, enabling precise human resource allocation and dynamic workload balancing.
Leverages quantified performance data on effort hours and delivery quality to support customized training programs and career development pathways, fostering a stable and high-performing core technical team.
Helps enterprises establish mechanisms for knowledge asset accumulation and reuse, transforming design experience and solutions scattered across individual computers into enterprise-level, searchable, interlinked, and iterative structured knowledge—accelerating new employee onboarding and intergenerational technology transfer.
Provides fine-grained control over work and knowledge-sharing permissions, allowing temporary access rights to be dynamically assigned based on operational needs, ensuring both strict security control and business flexibility.

Sample Testing Management

Sample and Testing Management (SIPM/LIMS) is built on SIPM Software's proprietary no-code platform, sharing the same modeling tools, underlying architecture, and database as SIPM/PLM. This enables deep, seamless integration, creating a unified platform for test data and business management that meets the requirements of laboratory management systems.

Enables full digitalization of the entire process—from commissioning requests, sample registration, intelligent task assignment, raw data entry, to automatic report generation—ensuring compliance with regulatory requirements and guaranteeing test traceability and compliance.
Provides structured and dynamic management of core laboratory elements, including personnel qualifications, equipment calibration, sample tracking, testing methods, and environmental conditions.
Supports online business requests, intelligent task assignment, visualized testing processes, automated data collection, and refined result analysis, significantly improving testing efficiency and data accuracy.
Real-time integration of test data with PLM master data such as product design, BOM, engineering changes, and quality information enables rapid feedback of quality issues to R&D and manufacturing teams, driving closed-loop continuous improvement.

Prototype Manufacturing Management

Prototype Manufacturing Management (SIPM/PMS) focuses on enabling dynamic, end-to-end management of the customer's prototype development process—from requirement analysis, trial preparation, and trial production to prototype delivery. It covers design, BOM, process planning, materials, and production trial preparation and planning, facilitating efficient cross-departmental collaboration. Through real-time monitoring and data-driven decision support, the system ensures that the prototype manufacturing process is controllable, traceable, and significantly improves overall work efficiency and productivity.

Centrally manage trial production tasks, material preparation, process routes, and delivery milestones to ensure on-time, high-quality prototype delivery.
Proactive resource alerts: Automatically identify gaps in material inventory and manufacturing resources to prevent production stoppages due to missing parts and reduce costs from duplicate or over-purchasing.
Full traceability of trial process data, material usage, and quality issues enables rapid root cause analysis and continuous improvement.
Digitalized collection, analysis, and early warning of key data from new product trials unlock data value and support process optimization.
Real-time visualization of core metrics such as project progress, cost distribution, shipment volume, and issue statistics, with drill-down capabilities and cross-department collaboration support to enhance decision-making efficiency.

FMEA Management

SIPM/FMEA is deeply integrated into the SIPM PLM platform. Based on the AIAG-VDA Fifth Edition standard and centered on the "Seven-Step Approach," it combines the AP Matrix, dynamic collaboration, and knowledge base-driven methods to enable a full-process, structured, and closed-loop risk management workflow—from DFMEA to PFMEA and on to Control Plans.

Seamless integration of standards with out-of-the-box usability, featuring built-in unified AIAG-VDA templates, support for multiple customizable S/O/D (Severity, Occurrence, Detection) scoring criteria, intuitive operation, and flexible rule configuration.
Guided full-process workflow based on the seven-step method, with the system structuring and presenting functional analysis, failure analysis, risk assessment, and optimization measures step by step—ensuring clear logic and lowering the barrier to use.
Enterprise-level FMEA knowledge base supports the import of project-specific or foundational FMEAs, enabling knowledge content to be synchronously updated, reused, and referenced during the analysis process, thereby transforming experience into organizational assets.
Intelligent association and reuse: Functions, failure modes, characteristics, requirements, parameter diagrams, and other elements are fully interconnected; supports copying of foundational FMEAs in whole or in part, significantly improving analysis efficiency.
Closed-loop risk management: Built-in issue tracking with closed-loop mechanisms, supporting both rapid resolution and standard 8D processes; automatically validates AP (Action Priority) levels and intelligently alerts users to high-risk items.
Unified data source with PLM ensures consistency, synchronization, and traceability of design, process, and quality information, enabling integrated collaboration and control.

AI Intelligent Applications

By deeply integrating AI with PLM, static data assets are transformed into dynamic intelligent capabilities, accelerating R&D innovation, process optimization, and knowledge reuse.

Intelligent Knowledge Engine: Based on enterprise R&D outcomes, process documents, and experiential data, it builds a classified vector system to enable automatic knowledge organization, semantic search, and precise push.
Content-Level Intelligent Search: Integrated with an AI engine, it supports full-text semantic search within the PLM system, enabling associative access and referencing of design documents, BOMs, change records, and other content at the granular level.
Intelligent Process Generation: Uses AI to identify part machining features, automatically matches process rules, and generates optimal processing routes, improving both efficiency and consistency in process planning.
Extensible AI Architecture: Supports integration with mainstream AI frameworks, allowing enterprises to train proprietary large models and deeply embed them into PLM for customized intelligent applications.
Data-Driven Decision Making: AI automatically analyzes multi-dimensional data from projects, costs, quality, and more, assisting in budget optimization, risk, and resource allocation—driving management evolution from "experience-driven" to "intelligence-driven decision-making".

Industry Advantages

1 › Global leading MDA system modeling tool, enabling flexible and personalized system modeling.

Based on a Model-Driven Architecture (MDA), the low-code/no-code system construction platform enables direct mapping between business logic and system implementation. It supports continuous iteration as management capabilities evolve, allowing flexible and personalized system modeling while ensuring high stability.

2 › Integrated interdisciplinary collaborative design management for mechanical, electrical, and software systems.

The PLM platform centrally manages product data across disciplines—including mechanical, electronic, software, and packaging—eliminating data silos between multiple specialties and ensuring consistency, integrity, and full lifecycle traceability of design data from system architecture down to component-level details, effectively supporting the integrated development of transportation and logistics equipment.

3 › Platform-based product configuration management helps enterprises transform from Engineer-to-Order (ETO) to Assemble-to-Order (ATO).

Supports product module selection and customizable configuration rules, significantly lowering configuration complexity and improving the efficiency of business personnel in maintaining configurations independently. Enables rapid response to business demands such as "multiple specifications, clinical scenario differentiation, diverse regional certification requirements, and high delivery responsiveness," greatly shortening order fulfillment cycles and driving the enterprise’s efficient transformation from Engineering-to-Order (ETO) to Assemble-to-Order (ATO).

4 › The only PLM system that supports structured management of FMEA Fifth Edition.

5 › Unified Management of Testing and Inspection Data

Fully covers the six key elements of laboratory management—"personnel, equipment, materials, methods, environment, and measurement"—to build standardized testing processes and a unified data platform. Enables automatic assignment of test tasks, real-time collection of process data, structured entry of results, one-click report generation, and closed-loop feedback on issues. Ensures testing data is authentic, complete, compliant, and auditable, supporting product quality assurance and certification requirements.

6 › End-to-End Management of Prototype Trial Production

Covers the entire lifecycle of prototypes—from requirement initiation, trial production planning, BOM and process preparation, material readiness, production execution to delivery and acceptance—integrating collaboration across R&D, process engineering, procurement, and manufacturing departments. Enables visible trial plans, transparent resource status, and timely issue response, significantly improving prototype delivery efficiency and first-time success rate.

7 › Exceptional system stability, supporting high concurrency, large data volumes, and highly complex processes.

The server is built on a mature Java technology stack, offering cross-platform high availability and elastic scalability. It supports smooth operation of core business functions under long-term high loads, effectively handling scenarios with concurrent operations by multiple teams and high-traffic business peaks. Multi-node collaboration and parallel branching workflows can be configured via simple drag-and-drop, enabling rapid adaptation to evolving business needs. Through MDA-based modeling, the system allows flexible functional customization without modifying source code, balancing operational agility with long-term system stability.

8 › Supports group-level multi-organization deployment and global multi-language, multi-time-zone applications.

Supports group-wide unified deployment across multiple factories and R&D centers; language packs can be self-extended using standard templates, easily adapting to global localization needs; the client automatically identifies and dynamically displays the local time zone (including intelligent switching between daylight saving and standard time), ensuring consistent data, synchronized processes, and a uniform user experience for multinational teams on a single platform, supporting efficient global operations.