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Max Strålin

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Latest activity by Max Strålin
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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...

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    Max Strålin created an article,

    Selling on Amazon: How to get the Declaration of Conformity in 1 day?

    Amazon obligates sellers on its European sites to present their products’ Declaration of Conformity (DoC). Many sellers don’t know anything about this requirement until they are notified by Amazon ...

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    Max Strålin created an article,

    Applying the new UKCA marking on products

    The UKCA marking, or otherwise said ‘UK Conformity Assessed’ marking, will be the new product safety marking in the UK and replace the CE marking on certain products in the event of a ‘no-deal’ Bre...

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    Max Strålin created an article,

    Top 21 Myths About PPE (Personal Protective Equipment)

    When it comes to PPE, there are a lot of grey areas and confusion about: How much PPE do I really need to wear to get done with a specific task? What type of gloves should I use to have enough prot...