The ACHIEVE Blog

Insights on risk management topics and tips and techniques for implementation.

 
Tips for improving collaboration in risk management collaboration quality culture risk management Jan 22, 2024

Note: This is an excerpt of a podcast originally published on the Let's Talk Risk! newsletter. Listen to the full podcast here.


The practice of risk management in a...

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ISO 14971 Fundamentals: Reasonably Foreseeable Misuse iso 14971 fundamentals reasonably foreseeable misuse Dec 06, 2023

Reasonably foreseeable misuse in the context of ISO 14971 is more than use-error.

Note: this article is a summary of the original article published on the Let's Talk Risk! newsletter. Read the...

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Webinar - 7 essential elements of a risk management plan iso 14971 compliance risk management plan Oct 11, 2023

Note: this article presents an excerpt of a webinar presented to subscribers of the Let's Talk Risk! knowledge-letter. Watch the full webinar here and subscribe.


Good...

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Feeling stuck? Focus on patient safety, not compliance. patient safety risk management safety culture Sep 25, 2023

We are stuck in a system focused on compliance. Switch your focus to patient safety instead to get unstuck!

If you ask anyone in the medical device industry why they do risk management, you are...

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Case study: using post-market data to evaluate changes in risk level hazardous situation postmarket surveillance probability risk analysis Sep 18, 2023

Note: this article is a summary of the original article published on my Let's Talk Risk! newsletter. Read the full article here.


Summary

This case study provides an easy way to estimate...

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Quick Tip - Be aware of the effect of risk perception risk analysis risk evaaluation risk management risk perception Jul 20, 2023

People perceive risks differently. Each one of us has our own perception of risk, which affects our judgments and decisions.

Research shows that risk perception influences our judgments and...

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Tips for a risk-based approach to auditing Quality Systems achievelivesessions mdsap qms audit risk based risk based auditing Jul 17, 2023

Medical devices are heavily regulated across the world. In general, manufacturers are required to establish an effective Quality System to comply with regulatory requirements for continued market...

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Maximize the value of your risk management file as a communication tool best practices effective communication helpful tips iso 14971 compliance risk management file Feb 27, 2023

As a medical device manufacturer, you are required to establish and maintain a risk management file for ISO 14971 compliance. But did you know that you can maximize the value of your risk...

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There is more to hazard analysis than FMEA fmea hazard analysis iso 14971 fundamentals risk analysis Feb 21, 2023

ISO 14971 requires identification and documentation of hazards and hazardous situations as part of risk analysis. If you are using an FMEA as the only way to document applicable hazards and...

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Understanding reasonably foreseeable sequence of events for ISO 14971 risk analysis event tree analysis hazardous situation iso 14971 fundamentals risk analysis sequence of events Feb 13, 2023

A clear understanding of reasonably foreseeable sequence or combinations of events leading to hazardous situations is critical for identifying risks associated with the use of a medical device. In...

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3C's to consider before selecting an ISO 14971 training course for certification iso 14971 certification iso 14971 training risk management Feb 06, 2023

If you are looking to get certified in medical device risk management according to ISO 14971, you are probably finding it hard to select the right ISO 14971 certification course that can...

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Confused about defining a hazardous situation? You are not alone! fmea hazard hazard analyis hazardous situation iso 14971 Jan 30, 2023

There is a lot of confusion in the medical device industry about the term hazardous situation. It is a common practice in the industry to equate failure modes to hazardous situations, but that is...

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