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Max Strålin

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Latest activity by Max Strålin
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    Max Strålin created an article,

    Medical Device Safety: 5 Methods for Safety Cost Estimation

    Except being reliable, each medical device put on the market must also be safe and never operate or fail in a way that can be harmful to the user. An important factor determining the market success...

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    Max Strålin created an article,

    11 Types of Medical Device Design Testing

    First, what does testing mean? The word “testing” can have several meanings, some of which are: Establishing confidence that the medical device does what it is supposed to do; Detecting specifi...

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    Max Strålin created an article,

    8 Tools For Medical Device Quality Control

    The quality of medical devices can be assured by using one of the many basic tools developed over the years for use in quality work. As examples of such methods can be mentioned Pareto diagram, che...

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    Max Strålin created an article,

    What is Risk Assessment and Control Table (RACT)?

    The RACT is a large table, called by many other names (e.g. risk matrix, risk analysis chart, risk table). It is a risk management tool that integrates the results of all the analyses performed at ...

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    Max Strålin created an article,

    Medical Devices: Risk Management Process in 7 Steps

    According to ISO 14971, each manufacturer of a medical device must document the risk management process and be able to provide the specifications for such a process to the relevant authorities upon...

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    Max Strålin created an article,

    Medical Device Risk Evaluation And How To Determine The Risk Acceptance Criteria

    The risk evaluation refers to the moment when each manufacturer must determine if the residual risks posed by their medical device are within the acceptable limits when compared against the criteri...

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    Max Strålin created an article,

    The BXM Method in the Safety Risk Management for Medical Devices

    The BXM method relates to performing decomposition of the medical device system, followed by risk analysis on the parts of the system and finalised with an integration of the underlying reports int...

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    Max Strålin created an article,

    3 Methods for Risk Estimation

    Let’s first say what risk is! Risk can be described as a combination of the probability of occurrence of harm and the severity of that harm. Three commonly used methods could help estimate the risk...

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    Max Strålin created an article,

    5 Tools for Performing Medical Device Risk Analysis

    Various tools can help you identify the hazards for your risk analysis, and the choice on which and how many of them will be used is yours. Of course, the use of more than one tool reduces the like...

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    Max Strålin created an article,

    5 Critical Factors Important To Medical Device Risk Assessment

    Medical device manufacturers must deal with numerous government regulatory organisations whose primary responsibility is to enforce factors such as product safety, effectiveness and proper record k...