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Author Archive | marialofdahl

News for ISO 10993-1:Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process.

ISO 10993:2009 Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process has a secondary objective of avoiding redundant in-vivo tests. But even if that is true for Europe, important markets such as US and China still require that all the tests are done, so the question is whether the possibility […]

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Impressions from Medtech Investment Day

On Wednesday, I was booked for two practice sessions for my pitch. The idea is that you should present the company in 4 minutes. Four minutes is an incredibly short time! Apparently I did something right, because on Thursday Vivoline Medical AB won the contest MedTech Investment Day Award. But it was of course not […]

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Medtech Investment Day Award

Vivoline Medical AB with CEO Peter Sebelius from Gantus AB wins Medtech Investment Day Award. Today 24 medtech companies from Denmark, Finland, Norway and Sweden, presented their companies before a jury that would determine which company had the best chance to succeed globally. Peter Sebelius, who has a consulting assignment as the CEO of Vivoline […]

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Risk analysis

Risk analysis is a term often mentioned in relation to risk management and medical devices. The most relevant place for a medical device company to look for an explanation to this term is in the standard ISO 14971, that deals with risk management for medical devices. This standard states that risk analysis is: “Systematic use […]

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Project management

The word project, and hence the term project management, is both broad and somewhat abused in the sense that the words are used to mean many different things. In some organisations, there is a “project manager” and a “project” as soon as something is done, no matter how small it may be (when it is […]

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Best internationalisation plan

Vivoline wins prize in GoGlobal programme for the best internationalisation plan. October 20, 2010. As consulting CEO in Vivoline Medical, Peter Sebelius participated in the GoGlobal programme. At the final event, the participating companies presented their internationalisation plans and Vivoline won the “competition”.

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Lung evaluation device saves lungs

Today an article was published about a medical device that we are very proud to say that we have been very involved in developing. The device, called Vivoline LS1, can improve the quality of donated lungs, so that lungs that would otherwise be discarded can now be used. In the autumn of 2008, the development […]

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This year’s specialist according to Veckans affärer

This Wednesday I was at Berns salonger to attend Veckans Affärer’s super talent event. During the event, intelligent people discussed how companies can maintain their super-talents. It was an interesting afternoon, but more interesting still was the awards ceremony. A week before the event, the picture editor at Veckans Affärer called me and requested my […]

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