Articles tagged with: Polarion

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5 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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7 months 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).

Realization

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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7 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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9 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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11 months ago
 

Self-Driving Cars? You May Not Need to Own a Vehicle

Will you need to own a car in the future? Are self-driving cars going to replace the need for driving and car ownership?

It’s incredible to think instead of purchasing gas, we could instead buy seat-miles for vehicles parked in public stalls controlled by robots. Technology is becoming even more prominent in modern cars and trucks, driving a looming revolution of autonomy with sensors packed under dashboards and hoods.

The automotive industry is feeling the technology disruption – so our children and grandchildren may not need to own a car, or even learn how to drive.

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11 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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12 months ago
 

ALM-PLM Integration Helping Your Organization Develop Products

The Internet of Things (IoT) is changing how your business develops, manufactures, and supports products.

Software continues to “eat the world,” and our dependency on software continues to evolve, so there’s time for teams to suffer from rework and delays. Closing the gap between application lifecycle management (ALM) and product lifecycle management (PLM) gives your workers improved toolsets to implement during the development lifecycle. (more…)

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12 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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12 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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1 year 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…)