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Showing posts tagged with: risk assassement

Cup of Joe #47 - 2 Risk Modules

Cup of Joe #47 - 2 Risk Modules

It’s always good to think a step ahead, and exactly that is what our Cup of Joe wants to tell you about. qmsWrapper is constantly working on improvements and keeps up with the changes in the market that considers Medical Device startups and manufacturers. The new MDR is set to become applicable in May 2020. One of...
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The New Risk Module supports risk-based design

The New Risk Module supports risk-based design

Risk Analysis Module becomes a very important update, next to other features: Traceability Matrix, Process Engine, and Jira integration. Changes will make Risk Assessment much easier and clearer. In the medical device world, risk-based design and development is the new norm. For FDA clearance and CE Mark certification, ISO14971 is essential. And in May of 2020, the...
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THE NEW MDR 2020 – all you need to know

THE NEW MDR 2020 – all you need to know

  TO ALL MEDICAL DEVICE MANUFACTURERS   The New regulation (not directive anymore) is knocking on a door to Medical Device manufacturers. Transition time is running out, it’s just 6 months away. Are you ready? We will give you a few handy pieces of information that will provide you a clearer image of what is requested and help you go...
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4 steps how to carry out RCA

4 steps how to carry out RCA

Why? Where? How? When? What? Most problems don’t have obvious solutions. That’s why they remain problems, and that’s why, it’s necessary to be aware of underlying causes, especially when planning to carry out a root cause analysis. Root cause analysis is basically a process with a systematic approach for identifying a problem. It provides companies a way to prevent...
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Cup of Joe 43# - Treat the cause, not the symptom

Cup of Joe 43# - Treat the cause, not the symptom

What is the root cause analysis? Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means? It means to find what caused the problem, to find out not only what went wrong in the beginning, but how, when and why as well. Basically, RCA is...
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