Artiklar – Taipuva

06.12.2017

How to ease medical device development?

In this article I address four (4) different aspects for you to consider, when aiming to improve your ways of working. The context is medical device product development (incl. software) and the regulatory requirements of the industry – meaning the needed design control, safety risk management (ISO 14971) and the compliance to standards, FDA and other regional bodies.

23.11.2017

Medical devices, boost your way into Polarion!

Where to start when there are so many things to consider? Compliance to standards and regulations (e.g. IEC 60601, Medical Device Directive 93/42/EEC and FDA CFR 21 parts 11 and 820), safety risk management (e.g. ISO 14971), approval processes and many other mandatory procedures needing tool support.

11.10.2017

Simple template for quick and easy Polarion deployment!

Have you spent countless hours in workshops trying to create a perfect solution in one go? It is usually not the best way to start your ALM journey. That’s why Taipuva has developed an extremely simple Polarion template, which has just enough of everything to let you get your hands dirty in a jiffy.

09.10.2017

New methods enter into traditional engineering projects – Example of Stockholm Metro Extension

Helsinki area’s Länsimetro (The West Metro) project has been in the news in Finland due to project’s delays. There have been unexpected problems in final testing, especially in putting different systems together. One of the latest issues was with the control room, where 10 control systems have to be functioning without defects

02.10.2017

New Polarion ALM Release 17.2 is available

Polarion ALM 17.2. release is out. You will find new functionality and significant enhancements in many areas.

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