Articles tagged with: medical devices

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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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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…)

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1 year ago
 

ALM: Helping Make Sense of Evolving Medical Device Complexities

Software has evolved to become the key differentiator for medical device manufacturers, even though there are continued challenges.

The use of a unified application lifecycle management (ALM) solution, such as Polarion ALM, accelerates innovation while at the same time streamlining quality assurance and automating proof of compliance.

Despite the benefits of software innovation for medical devices, there are a number of strict quality requirements, product failure risks, and even more regulatory complexity.

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1 year ago
 

Morris Medical Monthly: RiskPack Data Type “Risk Control Measure”

Welcome back to Morris Medical Monthly: a recurring series for medical device development companies – and companies who are related to such companies – providing useful information about Polarion solutions and extensions.

Today we will discuss the subject of Polarion’s RiskPack extension, and have a look at RiskPack Data Types.

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2 years ago
 

Morris Medical Monthly: Overview of RiskPack Data Types

Welcome back to Morris Medical Monthly: a monthly series for medical device development companies – and companies who are related to such companies – providing useful information about Polarion solutions and Polarion extensions.

Today we will discuss the subject of Polarion’s RiskPack extension, and have a look at RiskPack Data Types.

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2 years ago
 

Morris Medical Monthly: How to use RiskPack (Part 2 of 4)

This entry is part 3 of 40 in the series Morris Medical Monday

Welcome back to Morris Medical Monthly: a monthly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will start on the subject of Polarion’s RiskPack extension, and have a look how to use RiskPack.

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2 years ago
 

The “Talk im Park” Conference

This week I was at a pretty interesting conference in Stuttgart called “Talk im Park” arranged from one of our solutions partner Methodpark. Available were a group of people interested in possible gaps developing software for medical devices. Due to this topic, I was presenting what gaps we identified when we talked to customers who moved from a MS Office solution to Polarion. The topic was called “Traceability? Audits? I don’t need to worry myself about that!!!” To see the full abstract visit: Talk im Park (more…)

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2 years ago
 

How Agile Development and Compliance Can Live Together in the Enterprise

Like many Polarion customers, medical device market leader NantHealth is the result of several companies merging to maximize strengths and synergies to better compete globally. These mergers resulted in multiple point tools and solutions vying for attention, budget, and control. Managers quickly realized that these process and information “silos” created significant disconnects and inefficiencies, constraining innovation and problem solving, introducing errors, and slowing time-to-market.

Photo: Todd HenryTodd Henry is the senior director of product development at NantHealth. He and his colleagues quickly understood that the new “combined” company needed to grow as one unified organization, accelerating delivery of high quality products, while maintaining constant compliance with FDA regulations. In their quest for a better way, Todd and his team found Polarion and discovered that Polarion solutions could take them further and faster than they had first imagined.

In our newest premium on-demand webinar, Todd Henry delivers valuable insights, practical tips, and lessons learned applying Polarion solutions at the enterprise level to be both agile and compliant in the highly regulated medical device industry.

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2 years ago
 

Morris Medical Monthly: RiskPack Basics (Part 1 of 2)

This entry is part 6 of 40 in the series Morris Medical Monday

Welcome back to Morris Medical Monthly: a monthly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will start on the subject of Polarion’s RiskPack extension, and have a look into RiskPack’s Basics.

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