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26.06.2020

CENIT's best practices approach for life sciences

Data and Process Integrity – Your Key to Faster Time to Market for Medical Devices

Rigorous product compliance and product quality management have always been an integral part of the product development process for life sciences companies. However, the steady increase of product complexity and corresponding higher investments for new product development require to rethink the approach to compliance management and the process of market introduction. 3DEXPERIENCE, a best in class, integrated business experience platform streamlines and transforms these processes and helps to consolidate fragmented data, documents and processes into one integrated environment.

Product Requirements Captured and Monitored

To master product complexity it is vital to capture all the functional and technical requirements of a new product or the revised version of an existing product. Monitoring these requirements over the course of the development process will ensure that the final product will fulfill these requirements when establishing product compliance dossiers for submission.

Through its requirements management capabilities the 3DEXPERIENCE platform becomes an enabler for the transformation of the overall development process, facilitating a measurable, value based assessment of product functions and capabilities and a true systems engineering approach for medical devices.

FDA Compliance Streamlined

Regulatory compliance for medical devices is defined in the Food and Drug Administration’s (FDA) 21CFR Part 820. It not only defines what needs to be submitted to the FDA for the application of market authorization, the 501(k), but also specifies all the data, information, and events that need to be captured over the course of the product development cycle.

Through its powerful concept of data and business process integration the 3DEXPERIENCE platform provides comprehensive data management and application functionality to manage the product compliance in a holistic way and to effectively manage key elements of FDA compliance such as

  • Design History File (DHF)
  • Device Medical Record (DMR)
  • Device History Record (DHR)

The integrated change management on the platform always makes sure to link the right versions of requirements, documents and compliance deliverables together in a consistent and auditable manner.

Fully Integrated Product Quality Management

Quality management and control for medical devices is essential to ensuring patient safety and meeting customer and market expectations. 3DEXPERIENCE enables a quality management process that is rooted in the Total Quality Management (TQM) approach and allows to manage and execute Corrective Action Preventive Action (CAPA) processes and Non Conformance Reports (NCR), yet again in its fully integrated environment.

Total control over quality at every stage of the product development lifecycle is the key to business success and developing pioneering advancements that change human lives for the better.

Irma Rastegayeva

An Integrated Platform to Transform your Business

The Dassault Systèmes 3DEXPERIENCE platform and related Industry Solution Experiences for Life Sciences enable medical device companies and their suppliers to accelerate product innovation while streamlining quality assurance processes and regulatory compliance.

Based on its comprehensive stack of foundational capabilities, e.g. for document management, and project management, the Life Sciences specific application functionality delivers exceptional value and enables faster time to market for medical devices. 3DEXPERIENCE ensures global, enterprise-wide visibility of product designs and a closed-loop process for proactively managing product quality and compliance.

CENIT’s “Ready-to-Grow” Approach

Based on extensive project experience and industry best practices our foundational "Ready-to-Grow" package offers a safe and rapid entry into the digital world of the integrated 3DEXPERIENCE platform.

Ready-to-Grow for Life Sciences includes a best-practice configuration of the essential product compliance and product quality management topics in order to deliver an out of the box solution with minimal effort from the start and thus facilitates a rapid deployment of your medical devices compliance solution. With this approach, we significantly lower project cost and also minimize the implementation project risk.

The project scope focuses on core compliance topics, business processes, and project management for FDA approval in a consolidated, collaborative platform:

  • Requirements management for medical device products
  • Design History File (DHF) management
  • Device Medical Record (DMR) management
  • Quality management for CAPA and NCR processes
  • 501(k) submission planning and dossier generation
  • Integrated change management for all product data and compliance documents
  • Collaborative project management

In collaboration with the premier IaaS (Infrastructure as a Service) partner 3DS Outscale the product compliance solution can be deployed in a matter of weeks.

Ready-to-Grow for Life Sciences provides the foundation for further, incremental digital transformation of the entire product development and manufacturing process on 3DEXPERIENCE, the leading business experience platform by Dassault Systèmes.

Transforming Medical Devices with sustainable innovation

Learn more on how the 3DEXPERIENCE platform and the Industry Solution Experiences for Life Sciences change the way you deliver medical device innovation to patients.  

Take the next step to a collaborative, multidisciplinary approach and download the brochure!

Authors

Paul Cassidy

Director Sales – PLM Solutions

+1 (810) 577-8713

 

Natalie Hickman

Account Executive – PLM Solutions

+1 (248) 912-2588

Contact person

Uta Keilhauer

Uta Keilhauer

Digital Content Manager

+49 711 78 25 32 68