Articles tagged with: Polarion ALM

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3 months ago
 

Join us: Improve your DOORS Experience [Webinar]

Product development is even more complex than ever, with users expecting smarter, better connected products. This change is making it even more difficult for innovation to match faster consumer demand – and your competitors are finding new methods to succeed.

Accelerating demands in product line engineering has forced many organizations like yours to capitalize on new opportunities, and it might be time to replace your legacy DOORS software with Polarion application lifecycle management (ALM). (more…)

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5 months ago
 

Internet of Things: Expanding into Medical Device Digital Enterprise

What is the definition of the Internet of Things (IoT)?

Gartner defines IoT as the following: “The Internet of Things (IoT) is the network of physical objects that contain embedded technology to communicate and sense or interact with the internal states or the external environment.”

If a medical device firm is implementing an IoT device, implied in the definition is a set of new product features related to the company ideation, realization and utilization systems. We will begin with a delineation some of the new capabilities and potential features IoT promises to bring to our devices.

This list will be fairly short to illustrate the difficulty in implementing this kind of technology, and the need for a digital model to support the effort not only in creation of the product, but just as critical, in management of the device after deployment.

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6 months ago
 

Join us: ‘Embedded Software Like Never Before’ Live Webinar

Software is leading a digitization revolution that is changing how modern products are designed, manufactured, and supported once released to the market. Further muddying the waters, network connectivity, the so-called Internet of Things (IoT), is disrupting traditional product development with more and more connected “Things” joining the fray.

Your development teams must adapt to accelerating product lifecycle times, more and more complexities, and growing regulatory compliance and standards conformance, with very little room for error during development – as well as in post-release scenarios. Increasing product demand for network make it difficult to identify and mitigate security vulnerabilities, failure scenarios, and other problems within a product’s embedded software. (more…)

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9 months ago
 

Current Tech Trends: I4.0 Continues Driving Development

Software is eating the world!” is a phrase that we’ve used in the past, and the technology continues to be extremely disruptive. As organizations try to sort out the Industrial Internet of Things (IIoT), sometimes referred to as Industrie 4.0 (I4.0), decision makers shouldn’t be too hasty in deployment plans.

Trying to figure out how to deal with punctuated innovation times, shrinking product lifecycles, and growing complexities is difficult. Customers must find methods to automate systems engineering while developing quality embedded software when consumers expect new and differentiated products. (more…)

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9 months ago
 

Making Sense of Current Application Lifecycle Management (ALM) Demands

Application lifecycle management (ALM) is no longer a solution that decision makers can ignore as part of their development plans.

Utilizing three core principles – collaboration, traceability, and workflow – it’s become easier to pass audits, compliance checks, and regulatory inspections using traceability that is easily implemented.

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10 months ago
 

Medical: A Risk Management Data Model

In our previous blogs I described [blog 1] and [blog 2] the regulatory requirements related to product risk and the elements required to build a database for use in the risk management system. The following is a discussion of the risk management data model and how the evaluation of risk can be accomplished using the design control previously discussed.

ISO 14971 Annex E characterizes the relationship between elements in the analysis of risk with the following flow chart:

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10 months ago
 

On-Demand: Business Benefits of ALM-PLM Integration

Organizations have the ability to bridge the gap between application lifecycle management (ALM) and product lifecycle management (PLM) – with proper ALM-PLM integration providing immediate business implications.

ALM-PLM integration provides the following benefits: Visibility across all assets, accurately link firmware with hardware, and collaboration and traceability of assets throughout all lifecycle phases. Engineers will not be overwhelmed by irrelevant data, as they are able to work in a domain familiar to them. Visit the ALM-PLM page by clicking here.

To view Business Benefits of ALM-PLM Integration on-demand, please click the following banner:

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10 months ago
 

Medical: A Traceability Data Model

To read the first blog in this series, Comprehensive Medical Device Risk Management, please click here. 

The first task of any product development process is generally to discover, define and link the items of interest for that product. This is best accomplished in a logic Flow Diagram, and is the basis for developing the Design V&V test plan, and risk Management framework. One example of such a diagram is the Polarion medical device template comprehensive traceability table (shown below).

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10 months ago
 

Comprehensive Medical Device Risk Management

One of the more difficult system development tasks in the context of a new medical device is how to organize and develop the product risk management strategy. When contemplating how to construct a system to manage this task, it’s necessary to consult not only company work flows and processes, but standards adopted by the competent authorities meant to standardize how medical device products are developed and approved.

Standards

At the time of this writing, the two standards used in definition and implementation of medical device risk management are ISO 14971:2009 and TIR 24971:2013. Europe has added to the mix by approving an EN ISO version of 14971, which is EN ISO 14971:2012. The EN version is different in several important aspects, and is required if the company is selling into Europe. (more…)

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10 months ago
 

Webinar: Are You Ready for Enterprise Agile?

Adopting Enterprise Agile can be a tough decision, as there is even more competition in the enterprise business world. As your development team needs to deliver better software – at an even faster pace – it’s a topic that we’ve discussed with you in the past.

It’s no longer just individual departments embracing agile software development, with companies showing increased interest in Enterprise Agile. Is your organization ready? We recently hosted a webinar that discusses some of the benefits – and challenges – related to Enterprise Agile.

During the recorded webinar, you’ll hear an introduction about Enterprise Agile and Polarion, lessons learned about the transition, and recommendations for better rollout. Click the following banner to download:

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