Medical ALM | Intland Software

Experts Talk: Medical Device Risk Management & ISO 14971 Compliance with Roche | Webinar recording

on-demand-webinarBy Intland Software 29 September 2020

Roche is adapting codeBeamer ALM for its Application Lifecycle Management processes including requirements, test, risk, and defect management. Mirko Klingauf, a Systems Engineer at Roche Diagnostics in Switzerland, is tasked with the implementation. In this webinar, Mirko talks about the implementation of ISO 14971:2019 – Application of Risk Management for Medical Devices in codeBeamer ALM…

Experts Talk: Integrated MedTech Delivery from Requirements through Design to Quality Documentation | Webinar recording

on-demand-webinarBy Intland Software 27 November 2019

Unifying the numerous complex stages of product development is a vital challenge for innovators of medical technology. An integrated approach to MedTech product delivery is the key to navigating traceability, risk management, and quality control in a way that supports regulatory compliance and high product quality. Watch this Experts Talk webinar recording from 27 Nov…

Experts Talk: Balancing Innovation, Risks, and Compliance in Medical Device Development | Webinar recording

on-demand-webinarBy Intland Software 13 November 2019

Developers of medical devices and other medical technology are in a difficult spot. Not only are they operating at the cutting edge of technology innovation, an inherently risky business. But they must also meet regulatory compliance requirements of various local or international standards. To top it off, they have juggle those aspects while outpacing competitors…

Intland Software’s Roundtable Discussion: Agile in Medical Technology

on-demand-webinarBy Intland Software 26 September 2018

Watch this on-demand recording of Intland Software’s Roundtable Discussion on 26 Sep 2018 featuring experts representing innovative medical device companies. Titled Agile in Medical Technology, this discussion covers the challenges and benefits of applying Agile practices in the development of cutting-edge medical technology. The discussion is moderated by Kelly Weyrauch of Agile Quality Systems. Agile software…

Automotive and Medical Technology Trends 2018

webinar recordingBy Intland Software 14 February 2018

As new technologies are expected to bring disruptive change to many industries, 2018 is set to be an exciting year in both automotive and medical innovation. In this webinar, we’ll analyze continued trends in automotive and medical development, and how technologies such as Big Data, Artificial Intelligence, and blockchain are expected to impact these industries…

Recap: Intland’s Medical and Pharma Conference 2017

UncategorizedBy Kristof Horvath 28 September 2017

Intland Software hosted its first-ever conference for medical device and pharma product developers on 27 September 2017. Professionals gathered in Stuttgart to exchange ideas and to discuss medical and pharmaceutical technology challenges and solutions in an increasingly digital, value-based healthcare market. In the footsteps of our user conference earlier this year (which featured talks by…

Agile in Safety-critical Development: a Medical Case Study

on-demand-webinarBy Intland Software 16 August 2017

This on-demand webinar recording is part of Intland Software’s Agile Training Course conducted through the summer of 2017. To access all four recordings of this session, sign up for the course! For years, Agile was considered an inadequate method for safety-critical development where a structured, organized, and fully documented lifecycle is necessary for compliance. The promised advantages…

Fritz Stephan Medical Case Study: Compliance in an Exceptionally Highly Regulated Environment

E-bookBy Kristof Horvath 9 May 2017

The increasingly rigorous requirements of safety-critical regulations pose a challenge to companies developing products for the automotive, medical device, railway, nuclear, financial, pharmaceutical etc. industries worldwide. Achieving compliance with a single standard can be difficult enough. But in the case of special products such as Fritz Stephan’s mobile emergency care units, several standards of multiple…

Medical Device Risk Management in Compliance with ISO 14971

MedicalBy Kristof Horvath 20 March 2017

With integrated, value-based healthcare moving health awareness and care “upstream” to prevent hospital care, medical devices are becoming more and more integrated in the lives of patients. That is, in our everyday lives, since digital healthcare technology is used even before (and specifically to prevent that) we become patients. The group of products regulated by…

Medical Device Compliance with IEC 62304 and ISO 14971

on-demand-webinarBy Intland Software 1 March 2017

With increasing market pressure to develop complex, high quality medical products as fast as possible, compliance with medical devices regulations and standards is becoming more and more of a challenge. Medical device developers worldwide are facing the problem of maintaining and enhancing product safety, reliability, and compliance with standards such as IEC 62304 (lifecycle processes)…

Keeping Pace with Changing EU Medical Regulations

MedicalBy Kristof Horvath 13 February 2017

When prompted with the question “What are the biggest challenges you are facing?”, 66% of senior management respondents to Emergo’s 2016 medical industry survey answered that changing regulatory requirements are affecting their companies the most. Somewhat related, the challenges of developing new products came in second with 45%. The importance of adhering to standards in…

Digital Health Industry: Medical Technology Trends in 2017

MedicalBy Kristof Horvath 27 January 2017

The rapid advancement of innovative technology today is propelling fundamental changes in several, if not all, industries. Due to the speed of current breakthroughs, this process is now widely referred to as the Fourth Industrial Revolution. As one of the world’s largest industries, the healthcare sector is greatly affected by this technology-driven transformation that is…

Setting up Medical Device Software Development Projects in Compliance with IEC 62304 and ISO 14971 (in collaboration with adesso AG)

on-demand-webinarBy Intland Software 19 October 2016

Due to traceability and compliance issues, managing complex medical device development projects is a challenge. In this on-demand webinar recording, adesso and Intland Software experts provide insights into efficient project management practice.Watch this webinar recording, prepared in collaboration with expert IT service provider adesso, to learn how to avoid traps and pitfalls, and how to…

Internet of Medical Things: Wearables & Other Modern Technologies in Digital Healthcare

MedicalBy Kristof Horvath 5 October 2016

There is hardly any aspect of our lives that disruptive and transformative technology is not affecting. Home automation, self-driving cars, IoT-connected kitchen appliances, smart bikes and similar products have gone from breaking news to being around us wherever we go. As humans increasingly accept technology as a part of their everyday lives, “digital healthcare” (the…

Medical, Automotive Product Recalls Increasing in 2016

UncategorizedBy Kristof Horvath 31 August 2016

A recent quarterly report by Stericycle ExpertSOLUTIONS about Q2 2016 shows a rapid increase in product recalls in a variety of markets. Recalls can be associated with a growing number of reported consumer injuries in the first two quarters of 2016, already surpassing the total number of reported injuries in 2015. Recalls have impacted all…

Why Medical Device Development Requires ALM Software?

MedicalBy Intland Software 6 July 2016

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 recently in 2015, the typical FDA approval process had grown to between 9-12 months. In…

Reacting to a Shifting Business Environment with Modernized Processes

MedicalBy Kristof Horvath 27 May 2016

Intland Software’s recently published case study with Medtronic investigates how the world’s leading medical technology company was able to overcome their most pressing challenges using our integrated Application Lifecycle Management platform, codeBeamer ALM. While an interesting story, it primarily sheds light on the technical details of how this medical tech giant was able to make this…

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

MedicalBy Kristof Horvath 11 April 2016

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 of major issues, the costs of the resulting recalls could affect the profitability of the…

Leveraging Traceability In Medical Device Development

OvumBy Intland Software 8 April 2016

Innovation in the Medical Device Development industry is hampered by complex standards and regulations and once the medical device prototype is developed and tested, it then faces a long approval process. Traceability is essential for ensuring compliance with medical device standards and regulations but this often overshadows its most important function as an enabler for…

2016 Trends and Challenges for Medical Technology Providers

MedicalBy Kristof Horvath 17 February 2016

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 and healthcare IT market hit the $100 billion mark by the end of 2015, and…

Agile + IEC 62304: Using Agile in Medical Device Development

MedicalBy Kristof Horvath 22 January 2016

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 the transition from Waterfall to Agile. While the advantages of Agile seem obvious, developers are…

Adopting Agile & Maintaining Process Control in Safety-Critical Device Development

ALMBy Kristof Horvath 18 November 2015

A lot of companies working in industries that are highly regulated by standards and guidelines (safety-critical industries, such as the medical, automotive and aviation sectors) still rely on the Waterfall/V-model development method when creating software for their end products. While this doesn’t allow them to take advantage of more modern Agile methods, they choose to…

Safety-Critical Software Development 101

ALMBy Kristof Horvath 4 November 2015

Building software to be used in safety-critical environments (for example, software embedded in medical devices, automotive or aviation systems, railway software, etc) is different to “ordinary” software development. As human lives may be dependent on these systems, it is imperative that they operate reliably, without the risk of malfunction, over extended periods of time, under…

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

MedicalBy Kristof Horvath 14 October 2015

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 collaboration between teams and team members. Like many other companies, DATATRAK found a way to…

Using Agile in Medical Device Software Development

MedicalBy Kristof Horvath 5 August 2015

Software is increasingly used in all kinds of physical devices to expand the functionality of (or even completely replace) hardware components. This has been a trend in recent years across various industries, and is also the case with medical devices. Software enables the sophistication of even relatively simple devices such as insulin pumps, bringing new…

Benefits of Applying an Appropriate Risk Management Lifecycle

ALMBy Reka Moksony 19 August 2014

Risk management is especially important for safety critical industries such as healthcare (with the design and manufacturing of medical devices), aviation & aircrafts, transportation, as well as the automotive industry due to the risks associated with the design of cars. Increasing complexity of such safety critical products increases risk for manufacturers as serious injuries or death could…

Tag Archives: Medical ALM