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Software Process & Data Management

Software Process & Data Management

Medical device products are undergoing dramatic changes to compete in an ever-changing and rapidly expanding market. One of the key enabling factors is the software embedded within these products. Sophisticated product-intelligence software driving this advanced functionality is highly complex and challenging as devices are only becoming smarter.

Disruptive behavior is forcing med-tech companies to innovate, or be left behind. Software engineering has never been more interdependent on electrical and electronic hardware systems and mechanical systems.

Medical device products are undergoing dramatic changes to compete in an ever-changing and rapidly expanding market. One of the key enabling factors is the software embedded within these products. Sophisticated product-intelligence software driving this advanced functionality is highly complex and challenging as devices are only becoming smarter.

Disruptive behavior is forcing med-tech companies to innovate, or be left behind. Software engineering has never been more interdependent on electrical and electronic hardware systems and mechanical systems.

Software Process & Data Management

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The need to manage sophisticated smart products in the medical device industry requires integrated software engineering solutions.  Our systems-driven approach to medical device product development marries systems engineering with an integrated approach to software engineering and product engineering.

Technologies such as model based engineering (MBE) enable the Digital Twin concept that allows for quicker product evaluations, robust functionality, and operational assessments which help to reduce development time and costs, all while ensuring the end product meets consumer need.

Software Process & Data Management

On-Demand Webinar | 28 Minuten

Intelligente Software für Medizinprodukte zur Optimierung der Konstruktionsvalidierung

Schaffen Sie durch unsere innovativen Lösungen die Grundlage für intelligente Konstruktionslösungen in Ihrem Unternehmen für medizintechnische Produkte.

Schaffen Sie durch unsere innovativen Lösungen die Grundlage für intelligente Konstruktionslösungen in Ihrem Unternehmen für medizintechnische Produkte.

Webinar ansehen

Lösungsfunktionen

Explore the key areas of this solution.

Bill of Materials Management

Provide a common source of materials information across your medical device organization, whether a basic or advanced BOM, in order to exceed market demand for more innovative and varied product offerings.

Extensions & Applications

Utilize out of the box integration with popular tools for a fast start and wide range of project templates. Free, open API's help your medical device organization build personalized apps and extensions.

Functional Safety

Accelerate functional safety compliance for ISO26262, Automotive SPICE, and CMMI standard.

ISO14973

Comprehensive, automated history of all artifacts facilitates proof of compliance - Integrate risk management processes leveraging the ISO 14971 template.

PLM-ALM Integration

Equip medical device development organizations with a single, cohesive product ecosystem, directly linking of ALM and PLM data and processes.

Product Requirements Engineering

Create, view and edit device requirements with familiar applications thanks to our integrated engineering lifecycle solution which enables a start integrated and stay integrated development process.

Software Agile/Hybrid Project Management

Achieve agility while protecting quality and compliance regulations at your medical device organization, all whole maintaining lean yet complaint approval processes.

Software Audits, Metrics & Reports

Improve decision-making and project execution with detailed analytics and real-time status reports created specifically for the medical device industry.

Software Build & Release Management

Release devices frequently and without compromising the consistency, integrity, or regulatory compliance of any product.

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