AB SCIEX, faced with mounting global environmental regulatory requirements, needed a system in place to ensure compliance of its products, track emerging regulations globally throughout its supply chain, and deliver quick responses to customers and legal authorities.
Dassault Systemes provides a business solutions platform on-site, online and on the cloud. We offer purpose-built solutions for medical device, pharma and biotech applications, as well as patient care companies to connect innovative virtual 3D designs with patients, physicians, and other research, regulatory, and clinical communities.
We have a workforce of more than 10,000 throughout 140 countries, serving 170,000 companies worldwide across 12 industries, including life sciences.
Our network of more than 3,500 partners includes research and academic institutions, as well as software, sales and service partners.
With a long-term vision focused on partnering with industry leaders, Dassault Systemes is majority shareholder controlled by Dassault Groupe. In 2012, our revenues were more than €2bn, with an operating margin above 30%.
Virtual 3D simulation software
Dassault Systemes provides a 3DEXPERIENCE platform, which enables life science clients to simulate fully functioning products, connecting innovative virtual 3D designs with patients, physicians, and other research, regulatory, and clinical communities. From the concept to delivery to the patient, drug manufacturers create and optimise a formulated product, and manage the delivery of the medicine to consumers, while gaining regulatory approvals.
With 3DEXPERIENCE, even the most challenging working conditions are addressed in a single platform, enabling collaboration, and a holistic view of product and process information at the corporate level to help you maximise market performance and improve patient outcomes.
Computer programmes for designing medical devices
Dassault Systemes’ 3DEXPERIENCE platform for the life sciences industry provides companies with solutions to ensure they have the right product, at the right place and time. Our ‘Licensed to Cure’ experience allows medical device companies to dramatically accelerate product design and evaluation with a repeatable and fully traceable creation process for product innovation, regulatory and quality management.
Improving design efficiency
At the department level, the ‘Licensed to Cure for Medical Device’ solutions help companies improve operational efficiency by better executing the various processes through a systematic approach, enabling companies to conduct more changes and accelerate the decision-making.
We provide the means to reduce the risk of uncertainty of the decision through impact analysis and a real-time visibility through a unified project management to better drive the business. The 3DEXPERIENCE Platform facilitates the reuse of best practices by enabling cross department collaboration in order to expand your business and set up a regulatory strategy.
Complete product and process traceability
Successful companies will control information, product complexity and regulatory compliance, and lead the market with breakthrough innovations; in addition to achieving quality, speed and cost targets.
Our ‘Licensed to Cure for Medical Device’ industry solution experience ensures a single source of information for design and a fully documented change process for both the product and process. It allows medical device manufacturers to be proactive rather than reactive to increasing demands.
High-quality and 100% regulatory compliance is assured via a virtual design history file (DHF) and up-to-date device master record (DMR) that is directly linked to post-market quality assurance business processes such as complaints, non-conformance reports (NCR), and corrective and preventative actions (CAPA).
Expedite regulatory reporting
Successful companies will position themselves to jump-start projects by leveraging structured business information based on customer feedback, suppliers or internal practices, while treating regulatory compliance as an asset in the development process. Compliance and innovation must become complementary rather than conflicting processes.
Pre-market authorisation and review process templates for the FDA’s PMA and 510(k) submissions, in addition to other European and Japanese regulatory submissions to speed-up approvals and collaboration across multiple groups in the enterprise so that breakthrough innovations can reach patients more quickly.
Direct link to patient and physician requirements
Our ‘Licensed to Cure for Medical Device’ industry solution experience enables you to create a virtual environment for gathering customer feedback and requirements that can be managed in a holistic environment with full traceability that is visible to all quality, regulatory, and engineering staff, and will ensure product safety, accelerate innovation and master regulatory compliance complexity.
The key benefits of our services include:
- Integrated framework for compliant innovation and embedding quality and regulatory best practices
- Faster time to market
- Increased quality
- Master regulation compliance
- Maximise IP reuse and select the best value to cost projects
- Optimise resource allocation
- Streamline the regulatory filing process to remove barriers to increasing innovation
- Full traceability and automated reporting and filing
An insulin pen may be small, but it is a precision instrument with a number of complex parts that must work in perfect tandem. Some pens are durable, containing a replaceable drug cartridge, while other disposable ones come pre-fi lled with the drug.
In an effort to improve the quality of information in medical device adverse event reporting, reduce recalls and improve patient safety, in 2007 the United States Congress passed legislation directing the FDA to develop regulations establishing the unique device identification (UDI) system for medical devices.
The implementation of unique device identification (UDI) will have a profound effect on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.
Beyond Trade-offs: How Medical Device Manufacturers can Balance Innovation, Quality and Compliance While Improving Profit
The medical device industry has always been dependent upon product innovation to drive growth. With today's aging global population and expectations for living to an older age, the medical device industry is poised for a sustained period of extreme growth fueled by a level of innovation that is scheduled to accelerate.
Connecting the Dots Between Quality, Engineering, and Regulation to Increase Innovation and Improve Operational Efficiency
Medical device companies often face responsibilities associated with developing, producing, and distributing products that improve quality of life.
Medical device companies are under a lot of pressure from all of their stakeholders, including patients, health care providers, shareholders and regulatory agencies around the world.
Dassault Systemes’ 3DEXPERIENCE Platform Adopted by Olympus Technologies Singapore to Accelerate Medical Device Time to Market
Dassault Systemes today announced that Olympus Technologies Singapore Pte Ltd, a leading endoscope manufacturer, has selected Dassault Systemes' 3DEXPERIENCE platform for the development of its medical devices.
Medical Device Company Lumenis Unifies Engineering and Business Processes with Dassault Systemes’ ENOVIA Version 6
Dassault Systemes, a world leader in 3D and product lifecycle management (PLM) solutions, announced today that Lumenis, the largest medical laser company in the world, has selected ENOVIA Version 6, after a meticulous evaluation process, to fully master the company's engineering information and business processes.
Dassault Systèmes Americas Corp
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