Risk Management — Blog — Exeed

Posts in Risk Management

Sharing Knowledge, Solving Problems: Risk Analysis, Benefit-Risk, & More

Sharing Knowledge, Solving Problems: Risk Analysis, Benefit-Risk, & More

We’re happy to share the recording of the most recent session of our webinar series, Sharing Knowledge, Solving Problems. During this interactive Q&A session, Dr. Naveen Agarwal fielded questions surrounding ISO 14971 with topics including risk analysis, ICH Q9, FMEA, PHA, and more. We’re thrilled to see the community coming together to discuss questions and obstacles in the risk management industry. This dialogue is key to developing understanding and finding solutions to future challenges.

Risk ManagementNaveen AgarwalNovember 11, 2020webinar, Risk management for medical devices, Risk Management, risk management policy, ISO 14971 Basic Concepts, ISO 14971:2019, ISO 14971, Understanding ISO 14971:2019, PHA, risk analysisComment

Begin Your Risk Analysis with Intended Use and Foreseeable Misuse

Begin Your Risk Analysis with Intended Use and Foreseeable Misuse

One of the challenges in risk analysis of medical devices is the diversity of use scenarios based on the target medical purpose and use environments. That is why ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices, requires that risk analysis begin with a clear understanding of the intended use and reasonably foreseeable misuse.

Risk Management, Regulatory ComplianceNaveen AgarwalOctober 12, 2020ISO 14971 Basic Concepts, ISO 14971:2019, ISO 14971, Understanding ISO 14971:2019, Risk analysis concepts, risk analysis, intended use, forseeable misuseComment

Introducing Exeed’s New Webinar Series: Sharing Knowledge, Solving Problems

Introducing Exeed’s New Webinar Series: Sharing Knowledge, Solving Problems

Exeed is happy to introduce our new webinar series, Sharing Knowledge, Solving Problems, hosted by Dr. Naveen Agarwal. These interactive webinars are an opportunity for the medical device community to come together and discuss questions and obstacles surrounding ISO 14971 and risk management.

Risk ManagementNaveen AgarwalSeptember 29, 2020webinar, ISO 14971:2019, ISO 14971 Basic Concepts, ISO 14971, Understanding ISO 14971:2019, risk management, risk management videoComment

5 Elements of a Risk Management Policy

5 Elements of a Risk Management Policy

Clause 4.2 of ISO 14971:2019 requires the top management to define and document a policy for establishing criteria for risk acceptability. This policy must provide a framework to ensure that criteria are based on applicable national or regional regulations and relevant International Standards, stakeholder concerns and generally acknowledged state of the art.

Risk ManagementNaveen AgarwalAugust 26, 2020ISO 14971 Basic Concepts, ISO 14971:2019, ISO 14971, Understanding ISO 14971:2019, understanding risk management, risk management plan, risk management policy, policy, risk management, risk management videoComment

Understanding the Risk of Using Reprocessed N95 Masks During Covid-19 Pandemic

Understanding the Risk of Using Reprocessed N95 Masks During Covid-19 Pandemic

Shortages of N95 masks are forcing desperate measures. Decontamination of masks for multiple uses is a viable, low-risk-option under these extreme circumstances.

Risk ManagementNaveen AgarwalApril 6, 2020covid-19, COVID-19, coronavirus, coronavirus crisis, conronavirus pandemic, N95 masks, n95 mask shorage, FFRs, filtering facepiece respirators, CDC guidanceComment

ISO 14971 Basic Concepts – Hazard, Hazardous Situation and Harm

ISO 14971 Basic Concepts – Hazard, Hazardous Situation and Harm

These terms are foundational to risk analysis, yet they are poorly understood and often incorrectly applied.

Risk ManagementNaveen AgarwalFebruary 24, 2020ISO 14971, ISO 14971:2019, ISO 14971 Basic Concepts, Risk analysis concepts, Hazard definition, Hazardous situation definition, harm definition, international standard for risk managementComment

Risk Management Lessons from a Class I Recall

Risk Management Lessons from a Class I Recall

A class I recall of a pediatric device used to provide life-critical breathing support offers important lessons for Risk Management

Risk ManagementNaveen AgarwalFebruary 10, 2020Class I Recall, Pediatric Device Recall, Babi.Plus Pressure Relief Manifold, Babi.Plus Pressure Relief Manifold recall, quality management system, QMS, Bubble CPAP system, medical device recall, medical product recallComment

Risk Management Tools and Tips for Project Managers

Risk Management Tools and Tips for Project Managers

Risk management is critical to the success of any project. Here are a few tools and tips you can use to manage project risks.

Risk ManagementNaveen AgarwalJanuary 13, 2020perception of risk, risk perception, risk perception factors, project manager resources, tips for project managers, tools for risk managementComment

The Softer Side of Risk Management

The Softer Side of Risk Management

Everyone feels differently about risk. In this video presentation, we explore how individual perceptions influence risk analysis and decisions.

Risk ManagementNaveen AgarwalNovember 22, 2019risk perception, video presentation, risk management video, perception of risk, risk factors, risk perception factors, risk culture, effective risk-based decisions, medical device safety, bias of riskComment

A Risk Management Tool for MedTech

A Risk Management Tool for MedTech

Objective classification of adverse events has been a challenge for the industry. An outcome-based, medically-focused classification framework offers a more robust approach.

Risk ManagementNaveen AgarwalSeptember 11, 20195-point grading scale, clavien-dindo classification, medtech, risk management surgery, surgery, medical device, medical safety, medical risk management, surgical complicationsComment

Cybersecurity is the Next Frontier of Risk Management

Cybersecurity is the Next Frontier of Risk Management

As medical devices increasingly become more interconnected with other devices, hospital networks and even smartphones, cybersecurity risks are quite real. Managing these risks is a product life cycle issue because they are continually evolving and may arise due to circumstances not completely foreseen during their development.

Risk ManagementNaveen AgarwalAugust 5, 2019cyber security, medical device, medical device safety, medical device cybersecurity, FDA safety, medical device recallsComment

Lifting the Curtain on Alternate Summary Reports

Lifting the Curtain on Alternate Summary Reports

All ASR data files going back to 1999 are now available on FDA’s website. It is a large data set with over a million individual reports of device related injuries and malfunctions. We have started looking into this data and plan to provide insights that will help all of us better understand this information.

Risk ManagementNaveen AgarwalJuly 15, 2019Alternate Summary Reports, ASR Program, ASR program data, FDA ends ASR, Summary reports, medical device, medical device reportsComment

Can Your Risk Management Prevent a Recall?

Can Your Risk Management Prevent a Recall?

Even if you have not had a recall, or your products are not in the top medical specialties cited in this article, there is a good chance your Quality Management System (QMS) is also vulnerable to deficiencies in these areas.

Risk ManagementNaveen AgarwalJune 12, 2019FDA regulation, safety, medical safety, patient safety, Class I Recall, Medical Device RecallsComment

Achieving Excellence in Medical Device Benefit-Risk Assessments

Achieving Excellence in Medical Device Benefit-Risk Assessments

Medical devices save lives, but they are not without risk. Whether it is a disposable soft contact lens used on a daily basis, or an intraocular lens surgically implanted to treat cataract, use of medical devices can potentially result in serious injury or even death. There are thousands of medical devices on the market, but there are also reports of millions of injuries and thousands of deaths associated with these devices in the last 10 years.

Risk ManagementNaveen AgarwalApril 22, 2019FDA regulation, safety, medical safety, patient safetyComment

The Real Goal of Medical Device Safety Surveillance

The Real Goal of Medical Device Safety Surveillance

A defibrillator that locks-up after delivering the first shock causes delay in treatment which can result in serious injury or death. A needle-free closed system used to deliver chemotherapy drugs could release tiny plastic particles in a patient’s blood stream which can cause blockage. A pacemaker fails due to an unpredictable circuit error which can result in a life-threatening situation. These are just a few examples of Class 1 recalls recently announced by the FDA in a span of just a few weeks.

Risk ManagementNaveen AgarwalMarch 5, 2019Medical Device SafetyComment