The pace of digitalization is unprecedented and it is transforming our world by harnessing new technologies that mirror the physical world into a virtual entity, or what is best known as the digital twin. In the pharmaceutical and medical devices and diagnostics industry, smart medical devices will be used for diagnosis and treatments that will transform the way professionals treat and work with their patients.
Global regulators continue to emphasize mature quality assurance practices over baseline compliance activity. This heightened focus, referred to as the Case for Quality, along with globalization, economic factors, and a growing and competitive marketplace, are key factors driving smart manufacturing within the pharmaceutical and medical device industry. Similarly, greater device complexity and the increased occurrence of safety issues and recalls have heightened the need to enforce quality, efficiency and traceability in manufacturing operations.
Pharmaceutical and medical device companies are challenged to maintain controls for quality assurance and regulatory compliance across every phase of the device lifecycle. To do so, systemic approaches are needed to provide transparency, traceability and early-stage error detection. This is especially true as products continue to become more personalised and complex, and the marketplace continues to become more global and competitive.
There has never been greater opportunity to innovate in the design of medical devices. Advances in software and electronics enable smart, interconnected devices that promise improved user experience and effectiveness. Combined biochemistry and imaging advances that couple therapy, diagnostics, doctors, and patients increasingly rely on med-tech for better disease treatments.
As a result, those in the pharmaceutical and medical devices industry stay ahead of the curve and better meet consumer needs and demands.
Requirements management is a vital part of product development and process management, organisations in the pharmaceutical and medical device industry that choose to ignore this increase the risk miscommunication, costly mistakes and recalls. Capture, maintain, and deliver device requirements to everyone involved in the product development process with our requirements management solutions for pharmaceutical and medical device companies. Integrate customer needs throughout the product lifecycle by understanding the significance of change management.
Sirona is the dental technology and innovation leader, serving dealers and dentists worldwide for more than 130 years. The company develops, manufactures, and markets a complete line of dental products, including CAD/CAM restoration systems (CEREC), digital intra-oral, panoramic and 3D imaging systems, dental treatment centres and hand pieces.
Cercacor Laboratories, Inc. (Cercacor) is an innovator in health and athletic performance monitoring technologies. Based in Irvine, California, the company provides non-invasive tracking technologies that are used by leading hospitals around the world and licensed under the name Masimo rainbow SET® (signal extraction technology).
After an in-depth internal validation process, Cercacor selected Polarion solutions to unify its test and quality management initiatives.
Wright Medical Technology, Inc. (Wright) is a global orthopedic medical device company specialising in the design, manufacture and marketing of reconstructive joint devices and biologics. Wright uses Siemens’ solutions for product development, data and medical records management, collaboration, compliance, traceability and reporting, including using the software to meet FDA regulatory requirements.
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