_Building a Product Platform and Enhancing Audit Efficiency with Windchill

Industry

Manufacturing

Challenge

  • Complex documentation
  • Quality consistency
  • Regulatory adaptation

Technologies

Windchill PLM

Results

  • Streamlined processes
  • Enhanced quality compliance
  • Faster certification

Summary

Innovative Medical Manufacturing Company (IMMC), a Taiwan-based manufacturer specializing in plastic medical devices, partnered with Transition Technologies PSC to implement a Product Lifecycle Management (PLM) solution using Windchill. Founded in 1999 and headquartered in Miaoli, IMM offers a wide range of Class II infusion products and provides comprehensive production services, including medical component injection molding, automated assembly, packaging, and sterilization, all in a controlled clean environment.

To maintain the highest standards, IMMC adheres to the TFDA QMS and ISO 13485 quality systems throughout its development and manufacturing processes. To further enhance quality control, process efficiency, and document management, IMMC sought our expertise to integrate Windchill, ensuring compliance and continuous improvement in its product development and manufacturing operations.

Business challenges and needs 

  1. Complex Document Management: As IMMC’s product lines grew, so did the volume of documents needed for development and manufacturing. The manual document management process became increasingly inefficient, leading to errors and difficulties in maintaining organization.
  2. Ensuring Consistent Quality Standards: IMMC needed to maintain high quality across all products, but the existing quality control methods lacked automation, making it challenging to meet rigorous industry standards and reduce error rates.
  3. Navigating Certification Requirements: Supporting clients in obtaining and maintaining product market certifications required a streamlined and efficient approach to data management and document submission, which IMMC’s current processes struggled to achieve.
  4. Adapting to Evolving Regulations: IMMC faced the challenge of continuously updating its processes to comply with stringent and ever-changing global regulatory requirements, essential for maintaining certifications and market access.
  5. Scaling Production Processes: Rapid growth and increased demand required IMMC to scale its production processes efficiently. This growth highlighted the need for integrated digital solutions to optimize manufacturing and maintain high levels of efficiency and precision.

Solutions

  1. Digital Document Management: Implemented Windchill’s modules to digitize and centralize all product development documents, reducing errors and improving efficiency.
  2. Standardized Quality Control: Introduced automated workflows within Windchill to ensure compliance with TFDA QMS and ISO 13485 standards across all development stages.
  3. Efficient Certification Processes: Utilized Windchill’s tracking features to streamline certification management, enhancing accuracy and reducing processing time.
  4. Real-Time Auditing: Enabled real-time tracking of quality control activities, ensuring immediate issue resolution and compliance with regulatory requirements.
  5. Improved Collaboration: Integrated collaborative tools in Windchill to enhance communication and coordination across departments, increasing overall operational efficiency

Main results and benefits

  1. Enhanced Document Management: Document management efficiency improved by 50%, with a significant reduction in error rates.
  2. Improved Quality Compliance: Achieved full compliance with TFDA QMS and ISO 13485 standards, resulting in a 20% improvement in quality metrics.
  3. Faster Certification and Audits: Reduced time for regulatory updates by 30%, accelerating certification and audit processes.
  4. Ongoing Product Optimization: PLM’s data analysis features enable continuous product and process improvements, helping IMMC maintain a competitive advantage

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