The fastest and cheapest way to get hold of a (legal and therefore not free) copy of the ISO 14971:2019 standard on Risk Management is to purchase it from a web-store and download it as a pdf. But the
The most common question I get when delivering courses on risk management and ISO 14971:2019 is how you should be estimating risk. It is something that many of us have to do when we take part in risk management.
As you may know, in December 2019, the new updated version of the ISO 14971 was released. What does this update mean to you? Use this checklist template if you need help going over your own procedures and documents for
Many medical device manufacturers are working with FMEA. The concern is, does FMEA meet the regulatory requirements as to mark? Is FMEA the same as risk analysis? Or even risk management according to ISO 14971? This video is an
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 Google Sheets or similar to document
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
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 longer on the market. Even though the standard
Automating risk evaluation 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 this video I will
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 Européenne”. The
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
Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.
