1 week ago

Internet of Things: Creating Challenges for Medical Device Manufacturers

We recently posted “Internet of Things: Expanding Into Medical Device Enterprise,” and welcome you to part two of the ongoing discussion about medical devices and the Internet of Things (IoT).


Because field update of software is possible for hardware that is no longer manufactured it is now probable that more than one DMR will be approved for use with the variety of different product configurations (hardware and software variants).  In addition to this an update of the product in the field requires the DHR not be a static lot based document.  It is now time based.

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2 weeks 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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4 weeks ago

Software QA Needs Changing in Connected World

We expect connected devices to simply work. As more “things” adopt connectivity – thanks to the Internet of Things (IoT) – there is an evolving need for quality assurance (QA) and software test management, as development and QA departments face new challenges.

QA processes must be implemented throughout the entire product development lifecycle.

Polarion QA accelerates the ability to design, coordinate and track test activities using a single, collaborative QA environment. For organizations that face regulatory scrutiny, you’ll have the ability to pass any audit or compliance test with full project traceability.

To register for the “Software QA & Testing in a Connected World” webinar, please click here.

During the webinar, you’ll hear about the following topics:

  • Manage quality of code from cradle to grave
  • Leverage your existing Test Resources and artifacts
  • Jump start your projects with ready to use templates
  • Easily manage all defects, issues and enhancements from one platform
  • Seamlessly unify with legacy test automation tools and processes
  • Linking code to test cases and requirements

Polarion QA makes it possible for QA managers, test managers, and testers are able to efficiently design, coordinate, and track all test management activities in a single solution. Design your testing process specifically for your needs, with test cases controlled throughout the lifecycle.

Here are some of the benefits of using Polarion QA:

  • Ensure all relevant software requirements are covered by test cases and all test cases are consistent with their requirements
  • Customizable test specifications from ready-made templates
  • Use your existing test cases


1 month 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. Read the rest of this entry »

2 months ago

Holistic Approach to Application Lifecycle Management (ALM)

A holistic approach to application lifecycle management (ALM) allows your teams and workers to improve application development process using a single, unified solution for software requirements, coding, testing and release.

If you’d like to learn more, we recently hosted the following webinar, which is now available on-demand: “The Holistic Approach to Application Lifecycle Management.” Click the following banner to view the webinar:

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2 months ago

Why Software is Key Differentiator for Medical Devices

Software is an important part of emerging medical devices, but there is a growing list of potential risks that manufacturers must address.

Software has become the differentiator for medical devices, with customers facing audit findings, product recalls, delays in product release, and other key challenges. During the webinar, you’ll hear from Laurence Sampson, Siemens PLM Industry Expert for Medical Devices and Life Sciences, as he explains how unified ALM helps your organization address software challenges.

To view the webinar, please click the following link:

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2 months ago

Current Tech Trends: Connected Products Changing Industrial Landscape

The Internet of Things (IoT) brings connectivity to a wide range of new products, as software disrupts our personal and professional lives.

Good software quality is increasingly important, and has become a critical component for IoT-based solutions. Much of the attention surrounds consumer-based IoT products, but there are growing trends spurring innovation in Industry 4.0 (I4.0) products. As these products get smarter, product development complexity is increasing at a dizzying pace.

Organizations must show appreciation for end-to-end test management in their hunt to deliver new value-added products and features. Software development cycles are faster – with more frantic projects – and your organization must be ready to support short and rapid development sprints. Read the rest of this entry »

3 months ago

Polarion ALM 2016 SR2 – What’s New and Noteworthy

I always enjoy it that I get to announce new releases to our customers and the world. This latest release… version 2016 Service Release 2 (SR2) is a very special one. Why? For new and enhanced functionality? Yes. For improved performance and capability? For sure. For the issues that have been resolved? Of course. But there’s one thing more- something that’s unique to this release. Something you’ll notice as soon as you install it and fire it up. Have you guessed? Read on! Read the rest of this entry »

3 months ago

Polarion QA: Enhancing your Quality Assurance and Testing Procedures

Quality assurance (QA) is an important piece to the puzzle in your software development lifecycle. However, not relying on a complete QA solution might slow down your organization. You can make your process more agile by utilizing a collaborative QA and testing environment such as Polarion QA.

Polarion QA allows stakeholders access to data anytime/anywhere, while viewing shared documents and test cases. Interdepartmental communication is simplified, with full traceability visible from requirements to test verification.

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3 months ago

Embedded Computing Creating New Business Opportunities

Embedded software is becoming even more important in product development, leading innovation in connected and engineered products.

Although embedded software presents new business opportunities, there are also development and security complexities that must be addressed. More functionality is needed to support new and differentiated products, with demands on price, performance, size, and time to market are accurately discussed.

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