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 match patient DNA.
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 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 Devices 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.
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.
Here at OnePLM, we have built a reputation in successfully delivering Siemens software solutions, technical consultancy and support services to a wide variety of businesses across different industry sectors.
Talk with our experts and explore our customer portal to manage and track your questions, as well as explore our product advice and support guides.
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