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Medical Device Industry - Solution Components

PTC Integrity manages all systems and software development processes and connects all engineering artifacts, including risk management, requirements, models, code and tests. Its open architecture, streamlines the engineering process with true re-use and a collaborative development environment, simplifies compliance with automated generation of complex reports across disciplines, and provides accurate real-time visibility into product realization progress. With PTC Integrity, engineering teams improve productivity and quality and drive more innovative products into the market.

MD solution
  • Integrated Risk Management – Formal risk management is more than just a compliance requirement. When integrated with design and development it enables medical device companies to reduce the number of problem reports and customer complaints, minimize the probability of harm or the severity of harm to end users, as well as potentially lower maintenance costs associated with a device. Implementation of ISO 14971:2007 provides a framework for the application of specific methods for managing risk, while IEC 62304 details risk management in the context of medical device software components. PTC Integrity provides a configurable risk management process and framework to apply risk management methodologies such as Hazard Analysis, Risk Analysis and FMEA with traceability between risk management and design, eliminating the redundant and repetitive data entry and transfer inherent in using multiple systems. Integrating all disciplines also reduces late cycle rework and enables the generation of complex traceability reports for compliance audits at a mouse click

  • Requirements Management – Versioning, branching and base-lining of requirements and requirements documents enable the true reuse of requirements and other development assets at any point in the product lifecycle to effectively leverage investments across projects. PTC Integrity couples requirements re-use and change management with real-time metrics and full traceability between upstream Risks and Hazards and downstream Specifications and Verification and Validation activity. In addition, PTC Integrity presents all of this sophistication with a document-like interface that makes it easy to author and review documents and records.

  • Verification and Validation – Industry research shows that the root cause of 56 percent of all errors identified in projects are introduced in the requirements phase. Requirements based testing is a proven method of addressing this challenge, but is difficult to execute when using manual or separate requirements, test and design management solutions. PTC Integrity's single artifact and relationship model reduces risk of requirement errors slipping through with its automated cross-discipline reporting and dashboards, including key quality indicators such as requirements test coverage. PTC Integrity's traceability management gives product engineering companies unprecedented visibility into product realization milestone metrics and reporting, improving team collaboration and product quality

  • Software Configuration Management – PTC Integrity enables organizations to develop and deliver software in a collaborative and agile manner. At the core of the PTC Integrity application lifecycle management platform are process-driven software configuration and software change management (SCCM) capabilities that deliver traceability and transparency over all activities and artifacts across the application lifecycle. Re-use supporting component-based development is a necessary way of managing complex software development, especially when there are significant software inter-dependencies – such as in the embedded systems and medical device technology.

 

Document Actions
Reducing Manual Effort for Risk Management Compliance