Device Requirements Excellence

Balancing the customer feedback with Quality & Safety

The medical device industry is poised for a sustained period of extreme growth. High consumer expectations for better healthcare and advances in technology that improve quality of life are creating favorable market conditions. Yet rising costs and compliance concerns are forcing medical device companies to proceed with caution – balancing the competitive drive for product innovation and quality compliance with safety and traceability requested by regulatory agencies.


Our Licensed to Cure for Medical Device solution enables you to create a virtual environment for gathering customer needs and creating requirements that can be managed in a fully-visible, traceable and collaborative environment to ensure product safety and automate regulatory overhead.


The 3DEXPERIENCE Platform enables product managers to define tests to ensure that requirements meet expected product quality and customer needs and evaluate the impact of proposed engineering changes across multiple products and features. The Platform enables an immediate assessment of Change impact and audit traceability gaps in real time.

 

Key Benefits:

  • Realtime collaboration on same up to date version
  • End to end consistency from design intent to submitted to manufactured
  • Early design issues detection
  • Seamless Regulatory Compliance, avoid risk of errors, save time
  • Accelerated Change Impact Assessment
  • Immediate view of all sub-requirements, product parts, tests impacted

By leveraging the 3DEXPERIENCE platform that combines engineering, quality, and regulatory compliance business processes, we have moved closer towards becoming the R&D and manufacturing center of choice for our customer.

Lim HN Olympus Technologies Singapore