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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...

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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...

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CE-marking

If you intend to place a device on the market in an EU or EFTA country, it must be CE-marked by you as a manufacturer or part of a registered clinical trial. CE stands for “Conformité Européenne”. The...

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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...

View Article

Image may be NSFW.
Clik here to view.

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...

View Article


Image may be NSFW.
Clik here to view.

CE-marking

If you intend to place a device on the market in an EU or EFTA country, it must be CE-marked by you as a manufacturer or part of a registered clinical trial. CE stands for “Conformité Européenne”. The...

View Article

Where to buy and download the ISO 14971 standard as pdf

The fastest and cheapest way to get hold of a (legal and therefore not free) copy of the ISO 14971 on Risk management is to purchase it from a web-store and download it as pdf. But the prices may vary...

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FMEA and Risk management according to ISO 14971

Risk management vs FMEA Risk management for medical devices is a comprehensive approach, including requirements for planning the development of a device, to the requirements for a device that is no...

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What is the definition of a medical device?

Why it is important It can make a world of difference if you know what is the definition of a medical device and not. This is true both if you are selling a product that you don’t think is a medical...

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Where to buy and download the ISO 14971 standard as pdf

The fastest and cheapest way to get hold of a (legal and therefore not free) copy of the ISO 14971 on Risk management is to purchase it from a web-store and download it as pdf. But the prices may vary...

View Article

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Clik here to view.

FMEA and Risk management according to ISO 14971

Risk management vs FMEA A generic process for risk management according to ISO 14971 compared with the steps in Failure Mode Effects Analysis. Risk management for medical devices is a comprehensive...

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What is the definition of a medical device?

Why it is important It can make a world of difference if you know what is the definition of a medical device and not. This is true both if you are selling a product that you don’t think is a medical...

View Article

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Clik here to view.

How to have successful risk management workshops

Getting started on risk management is sometimes the hardest part. A series of well-thought out risk management workshops can give you a flying start in your work and allow you to avoid problems at a...

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Using MS Excel as a risk management tool: Risk evaluation result coloring

Using MS Excel as a typewriting tool does work, but by implementing a few hacks, you can get so much more out of it, and most importantly, you can save time. In the video below I will show you how to...

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Using MS Excel as a risk management tool: Automate risk evaluation

For most organizations, having a purpose-built risk management tool is just a dream (and/or completely unnecessary). In most cases you would then have to use a spreadsheet software such as MS Excel or...

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Risk management and ISO 14971 in one picture

The ISO 14971 standard is about 90 pages long, what if you could view it all in one picture?! The infographic gives you the overview of risk management that you have been looking for. If you liked this...

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The Secret Requirements List

You perhaps believe that you can read which requirements apply in the laws and standards for medical device manufacturers like ISO 13485 or 93/42/EEC, and to an extent that’s true. But to an increasing...

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CE-mark a medical device

If you intend to place a device on the market in an EU or EFTA country, it must be CE marked by you as a manufacturer or part of a registered clinical investigation. CE stands for “Conformité...

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The perfect project process for medical device product development

Having the perfect project process can be key in developing products in as short time as possible and as low cost as possible. It can allow you to exercise control over projects, especially in multi –...

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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...

View Article
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