Category Archive for "medical"

Risk Management in Medical Device Development

Why Medical Device Development Requires ALM Software?

Since 2011, medical devices have become increasingly sophisticated, and as the level of sophistication has increased, so has the time needed by the FDA to assess complex 510(k) medical device submissions (the majority of which are class 2 devices). Most

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Reacting to a Shifting Business Environment with Modernized Processes

Reacting to a Shifting Business Environment with Modernized Processes

Merken

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Medical Device Development: Common Mistakes in Risk Management

Medical Device Development: Common Mistakes in Risk Management

If you’re the least bit interested in safety-critical product development, there is one obvious fact you have probably heard a million times: in this area, product quality, reliability and safety are fundamental. In order to make sure your railway, automotive,
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medtronic

Case Study: How Does the World’s Largest Medical Technology Company Use codeBeamer ALM?

Development teams working on safety-critical end products (such as automotive embedded products, airborne flight equipment, railway equipment, and so on) really understand the importance of quality. One small fault in the product could cause catastrophic events, and in the case
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How to Validate Your ALM Tool in Medical Device Development?

How to Validate Your ALM Tool in Medical Device Development?

The application, as well as the benefits of using ALM platforms in the development of medical device software have been thoroughly documented by Application Lifecycle Management solution vendors (see this blog post) and medical device developers alike. However, the validation

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2016-Trends-and-Challenges-for-Medical-Technology-Providers

2016 Trends and Challenges for Medical Technology Providers

The medical device manufacturing industry is among the world’s fastest growing industry sectors. According to research, the majority of companies operating in this market are optimistic about the future of the industry in 2016. And for good reason: the medical electronics

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Agile + IEC 62304: Using Agile in Medical Device Development

Agile + IEC 62304: Using Agile in Medical Device Development

The reliance on embedded software is increasing as medical devices are achieving higher and higher levels of sophistication. Despite widespread discussions of the benefits that adopting Agile could bring to software development companies, some medical device developers still hesitate to make

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datatrak

DATATRAK Case Study: A Success Story of Traceability and Process Transparency

Most companies that choose to replace their set of single-point tools with an integrated ALM solution do so because they are facing certain well-defined problems. Common issues are the lack of process transparency, burdensome methods to ensure traceability, and difficult
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Risk Management in Medical Device Development

Medical Device Development: Process Safety Management

Software quality, safety and reliability are crucial for medical device development. There are some important requirements that should be considered if it comes to process safety. We need to establish traceability for all steps performed and for each intermediate step
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Compliance in Medical Device Development-01

Compliance in Medical Device Development – IEC 62304, FDA Title 21 CFR Part 11, ISO 14971, IEC 60601 and more

Medical device development is increasingly reliant on software to enhance the functionality, operation, maintenance or user-friendliness of medical products, eventually making it easier and safer for patients and doctors to use them. However, this also adds complexity to the development
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