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 ArticleRisk 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 ArticleCE-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 ArticleProject 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 ArticleRisk 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 ArticleCE-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 ArticleWhere 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 ArticleFMEA 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...
View ArticleWhat 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 ArticleWhere 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 ArticleFMEA 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...
View ArticleWhat 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 ArticleHow 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...
View ArticleUsing 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...
View ArticleUsing 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...
View ArticleRisk 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...
View ArticleThe 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...
View ArticleCE-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...
View ArticleThe 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 –...
View ArticleProject 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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