ISO 14971/Risk Management

You├óΓé¼Γäóve Evaluated Every Risk But Are You Properly Documenting Medical Device Benefits?

usr192162
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on Jun 02, 2021

You├óΓé¼Γäóve Evaluated Every Risk But Are You Properly Documenting Medical Device Benefits? Risk. Risk. Risk. Some days it can feel as though our sole mission as medical device regulatory professionals is to raise red flags about what could go wrong. Without a doubt, safety is where the focus should be. Yet, when ISO 14971 instructs […]

Oriel STAT A MATRIX
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on Jul 21, 2020

UPDATED 2/2/2022 This is the final post post in a three-part blog series on risk management and cybersecurity. In our first post we review general risk management requirements for cybersecurity. In our second post we discuss cybersecurity requirements for software and SaMD. If you are fairly new to risk management and cybersecurity compliance, you probably […]

Oriel STAT A MATRIX
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on May 01, 2020

As part of the risk review process, you’ll need to assess your risk management activities against the risk management plan on three levels: 1 – Has the plan been implemented appropriately’ 2 – Is the overall residual risk acceptable’ 3 – Are production and post-production information collection methods implemented’ The summation of answers to these […]

Oriel STAT A MATRIX
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on May 01, 2020

A big portion of risk management is evaluating and reducing risk. However, sometimes the likelihood of harm resulting from a hazard is quite low and mitigating that hazard may not provide any tangible reduction in risk in fact, it may diminish your devices benefits. Heres a quick example. Lets say you produce a blood glucose […]

Oriel STAT A MATRIX
0
on May 01, 2020

Your risk management plan outlines the process of how you will conduct risk management for a particular device, and it becomes part of your risk management file. Importantly, the process should be repeated throughout the life cycle of the device. The overall risk management process usually is documented in a general procedure containing common risk […]

Oriel STAT A MATRIX
0
on Jan 10, 2019

The next 12 months are sure to be a wild ride for medical device RA/QA professionals. ThereΓÇÖs a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase ΓÇô you may have seen it happening already. HereΓÇÖs what we are hearing from our clients […]

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Category: ISO 14971 Risk Management

You├óΓé¼Γäóve Evaluated Every Risk But Are You Properly Documenting Medical Device Benefits?

Overview of Medical Device Cybersecurity Standards and Guidance Documents

Risk Management Review, Reporting and Postmarket Planning

Medical Device Risk Control and Risk Management Tools

Creating a Medical Device Risk Management Plan and Conducting a Risk Analysis

6 Medical Device Compliance Issues That Will Demand More of Your Bandwidth in the Next 12 Months

Consulting & Auditing

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