Life-Science organizations are forced to rethink traditional document centric product development strategies if they are to support the increasingly sophistication and complexity of medical devices and combination products. Medical device organizations must shift their focus from managing documents to managing product data by selecting the right product lifecycle management (PLM)
This report is the result of an initiative launched by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) as part of an effort to assess and understand gaps in medical device quality. The work focuses on marketed product quality assurance, rather than pre-market activities. Its purpose is to provide a perspective on the state of medical device quality, as well as the challenges and opportunities for improvement.
Software is fast becoming the differentiator for manufacturers of medical devices. The rewards of software innovation are balanced by the risks and challenges of regulation, stringent quality requirements, market pressures and significant complexity. Balancing these competing interests requires tailored application lifecycle management tools that address the unique needs of medical devices companies.
This Whitepaper describes how Windchill helps regulated customers meet both the Part 11 regulation and Annex 11 by providing tools and technical solutions for complying with the regulation where the regulated user must also provide controlled processes and procedures to fully comply.
Medical device manufacturers operate in an increasingly regulated, safety critical environment, and frequently have many variants of parts, products, and product lines. PTC Integrity Lifecycle Manager provides essential engineering support to equip these device makers with efficient solutions to these key business challenges.
Learn about the changing industry trends impacting Medical Device Manufacturers’ Total Cost of Quality (TCoQ).
Proposal for a technology platform delivering a manufacturing system with improved productivity and energy performance with reduced operational costs. The proposed technology strives to reduce the energy consumption of a production system, by analyzing production schedules, energy consumption, idle times and volumes, along with utility rate schedules.
Describes differences between open and closed loop quality management solutions with benefits and consequences.
Map your Product Data Management process using the results from PTC’s PDM survey. Learn what other features other PDM user’s value most.
Manage, share and review Product Information with PDM. PTC makes data management easy with a single view to the latest multi-CAD and product data. Product design can securely share more consumable data with non-engineering stakeholders through role-based, self-service applications and 3D visualization technology. Based on Windchill software, PTC’s PDM solution removes the burden of data administration and lets product designers get back to what they do best – design.
Increasingly complex products designed with a mix of hardware, software, and connectivity are reshaping industries and redefining competition. Hand in hand with this, requirements are also growing. Organizations need a solid requirements management process to be successful. The article provides guidance on selecting the right requirements management solution.
With Creo Simulation Live, you define a few simple conditions, and the software works in the background to give you instantaneous, dynamic feedback in your Creo modeling environment.
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