Total Quality Drive your global regulatory strategy while ensuring unmatched quality, safety and efficacy
Face new challenges
Achieve regulatory compliance with exceptional quality standards
Improved medical device design, testing, clinical diagnosis and regulatory science along with ”in-silico” design, a shift toward biologics, and outcomes-based health economics can help accelerate the best products to market, reducing the overall Life Sciences industry attrition rate.
The goal is to create an integrated framework for compliant innovation, embed quality and regulatory best practices early in the development process, and to provide end-to-end product traceability throughout the lifecycle of the product. This process allows for higher quality, compliant products and faster regulatory approvals.
Ensure full regulatory compliance to:
Leverage regulatory intelligence to drive your global strategy
Reduce time-to-market and cost of market expansion
Ensure a consistent approach to quality, compliance, and regulatory activities across your extended ecosystem
Reduce risk of non-compliance, and improve traceability
Adopt the strategy
Patients are demanding higher quality and efficacious therapies
An integrated framework for compliant innovation, with embedded quality and regulatory best practices will help meet the demands of both government regulators and patient demands.
The 3DEXPERIENCE® platform is the only solution providing a single environment where manufacturers can work more closely with customers and develop customized solutions at unprecedented speed, efficiency, and cost. Enhanced multi-site collaboration allows them to manage and coordinate facility capacity, operations, inventory and resources in a way that’s profitable and efficient.
Building the future
The 3DEXPERIENCE® platform’s integrated business framework helps Osstem Implant eliminate traditionally disconnected processes and data, and increase the efficiency and accuracy of its product quality control.
"Gaining global market share calls for diversification and rapid delivery of innovative products to the consumer. Rising scrutiny around health related products forces us to devote much of our R&D to regulatory activities rather than on developing new products."
Head of the Information Systems Management Team, Osstem Implant