The ACHIEVE Blog

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

 
Understanding the term "Hazard" fmea hazard hazard analysis iso 14971 risk analysis Jan 14, 2023

At first glance, the term hazard appears quite intuitive to understand. According to the dictionary, it is the source of danger. But it is not so easy to precisely define it when doing risk...

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Weekly Live Series, Episode 6: Data Sources for Post-Market Surveillance achievelivesessions data postmarket surveillance Jun 22, 2022

Analysis of post-market data is critical to ensuring continued safety and effectiveness of our medical devices. It is also a requirement of ISO 14971:2019. A common practice in the medical device...

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Weekly Live Series, Episode 5: Effectiveness of Risk Management Process achievelivesession achievelivesessions effectiveness iso 14971 clause 10 management review process effectiveness Jun 06, 2022

ISO 14971 requires the top management to evaluate the suitability and continuing effectiveness of the risk management process for their medical device. But this evaluation is generally done rather...

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Weekly Live Series, Episode 4: Challenges of Using P1, P2 Approach achievelivesessions probability risk analysis risk estimation risk level May 23, 2022

Although not a mandatory requirement of ISO 14971, it is a common practice in the medical device industry to use the P1, P2 approach for estimating the probability of harm (POH). In many cases,...

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Weekly Live Series, Episode 3: Understanding Severity Levels achievelivesessions postmarket surveillance risk estimation severity warning letter May 16, 2022

In this episode, we focus on some of the practical challenges in implementing a severity scale to analyze the risk of harm associated with medical devices. Industry practice is to use a 1-5 scale...

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Weekly Live Series, Episode 2: Understanding Risk Estimation achievelivesessions risk analysis risk estimation May 09, 2022

Estimating risk of harm for your medical device is a requirement of ISO 14971:2019. However several practical challenges make it difficult to accurately estimate the risk of harm. This is partly...

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Weekly Live Series, Episode 1: Understanding Hazard Analysis achievelivesessions fmea hazard analysis live series risk management Apr 29, 2022

This week, we kicked off our Weekly Live Discussion Series! We talked about Hazard Analysis and why it becomes challenging if you try to combine it within a FMEA (Failure Mode Effects...

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Use these 4 steps to define hazardous situations and foreseeable sequence of events failure mode fmea hazard analyis hazardous situation risk assessment risk management Feb 15, 2022

If you are using an FMEA to define sequence of events and hazardous situations relevant for your medical device, you are likely having a difficult time. Here is an easier, more direct way to meet...

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Why You Should Use Standard Codes for Adverse Events in Your Risk Files benefit-risk fda interactive q&a iso 14971 postmarket surveillance Feb 06, 2022

Global regulatory authorities require the use of standardized codes for reporting adverse events. Here are two reasons why you should also use standardized codes and terms in your risk...

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How to Handle the Risk of Delayed Treatment fmea hazard analysis risk analysis risk assessment risk level severity Jan 29, 2022

Should we treat it as a hazard, a hazardous situation or a harm?

A diagnostic device gives a false or invalid result causing a delay in diagnosis and therapy. The software controlling a medical...

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How to Analyze Pre and Post-Mitigation Risk Levels fmea hazard analysis risk assessment risk level Jan 23, 2022

You are developing a new implantable medical device to facilitate a less-invasive surgical procedure compared to your current legacy medical device. How do you analyze and document both...

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Risk Management Lessons from an FDA Warning Letter complaints handling fda harm hazardous situation risk analysis severity warning letter Jan 16, 2022

When making decisions about investigating customer complaints using severity of harm, make sure the severity levels are correctly and consistently applied.

In a recent warning letter, the FDA cited...

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