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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

COVID-19 Treatments: Remdesivir Antiviral Drug

COVID-19 Treatments: Remdesivir Antiviral Drug

A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. The FDA has just approved a new antiviral drug, Remdesivir from Gilead Sciences, for treating COVID-19 patients needing acute care in a hospital. This treatment was available until now under an Emergency Use Authorization (EUA), but a full FDA approval will facilitate broader use.

Industry NewsNaveen AgarwalOctober 26, 2020covid-19 treatments, COVID-19, covid-19, coronavirus crisis, coronavirus pandemic, FDA, Remdesivir, antibody cocktailComment

COVID-19 Treatments: Regeneron Antibody Cocktail

COVID-19 Treatments: Regeneron Antibody Cocktail

Recently, several treatment options have become available to treat the most seriously ill COVID-19 patients. Antivirals such as Remdesivir and corticosteroids such as Dexamethasone are now being used to improve the recovery time and mortality rate among hospitalized patients. However, their curative effect against COVID-19 has not yet been established and these treatments are not widely available to the public.

Industry NewsNaveen AgarwalOctober 19, 2020COVID-19, covid-19, coronavirus crisis, coronavirus pandemic, coronavirus, EUA, FDA EUA, Regeneron, antibody cocktail, covid-19 treatmentsComment

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

ISO 14971 Basics – Using a PHA for Risk Analysis

ISO 14971 Basics – Using a PHA for Risk Analysis

Risk analysis is a key requirement of ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices. As outlined in Clause 5.1, the manufacturer shall perform risk analysis for the particular medical device as described in clauses 5.2 to 5.5. Here is how a Preliminary Hazard Analysis (PHA) can help.

Regulatory Compliance, Product QualityNaveen AgarwalOctober 5, 2020ISO 14971 Basic Concepts, ISO 14971:2019, ISO 14971, Understanding ISO 14971:2019, Risk management for medical devices, Risk Management, PHA, preliminary hazard analysis, Hazard definition, Hazardous situation definition, Risk analysis conceptsComment

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

FDA Authorizes a COVID-19 Diagnostic Test for Asymptomatic Individuals

FDA Authorizes a COVID-19 Diagnostic Test for Asymptomatic Individuals

One of the challenges in controlling the rate of new infections during the COVID-19 pandemic has been the lack of a diagnostic test specifically indicated for asymptomatic patients. According to some estimates, nearly 40% of the new cases of SARS-CoV-2 infections do not have any visible symptoms. As a result, many of those infected are not aware they are carrying the virus and may be inadvertently adding to the rising rates of new infections. A newly authorized diagnostic test for asymptomatic patients could help.

Regulatory News, Industry NewsNaveen AgarwalAugust 3, 2020COVID-19, covid-19, asymptomatic, diagnostic testing, diagnosis, FDA regulation, FDA News, FDA authorization, coronavirus crisis, coronavirus, FDA approves coronavirus tests, FDA approvalComment

5 Key Facts to Know About FDA’s Emergency Use Authorization Process

5 Key Facts to Know About FDA’s Emergency Use Authorization Process

The current COVID-19 global pandemic continues to remain out of control. As we write this blog, over 60,000 new infections are being reported on a daily basis in the United States, with a cumulative total of over 4 million cases and over 150,000 deaths reported since the pandemic first began here.

Regulatory NewsNaveen AgarwalJuly 31, 2020COVID-19, FDA, FDA Emergency Use Authorization, medtechComment

COVID-19 Testing – Understanding Antibody Tests

COVID-19 Testing – Understanding Antibody Tests

There is a lot of conversation about testing. Antibody tests, also called serological tests, help detect the presence of antibodies in blood samples. Antibody testing, when done at large scale, can help us understand the true rates of infection, mortality rates and level of immunity in the population on a regional basis. That is why these tests are a very powerful tool to help fight this devastating disease.

Regulatory News, Industry NewsNaveen AgarwalJuly 20, 2020covid-19, COVID-19, coronavirus criss, coronavirus crisis, coronavirus pandemic, FDA, FDA regulations, FDA approves coronavirus tests, antibody tests, serological testsComment

FDA Guidance for Face Shields and Respirators During the Covid-19 Pandemic

FDA Guidance for Face Shields and Respirators During the Covid-19 Pandemic

The medical landscape is constantly changing, particularly during the COVID-19 pandemic. With so much happening, there is a lot of confusion, particularly surrounding shortages of Personal Protective Equipment (PPE) and Face Masks. The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. In this article, we will cover Face Shields and Respirators.

Industry News, Regulatory NewsNaveen AgarwalJuly 10, 2020COVID-19, covid-19, coronavirus criss, coronavirus crisis, coronavirus pandemic, FDA, FDA regulation, FDA authorization, FDA News, respirators, N95 masks, face shields, face masksComment

FDA Guidance for Face Masks During Covid-19 Pandemic

FDA Guidance for Face Masks During Covid-19 Pandemic

Since the onset of the COVID-19 pandemic, there has been a lot of conversation surrounding the shortages of Personal Protective Equipment (PPE). In particular, we hear a lot about face masks and how they can help prevent the spread of COVID-19. But there is a lot of confusion out there - and many strong opinions - both for and against the use of face masks! In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

Regulatory News, Industry NewsNaveen AgarwalJuly 6, 2020COVID-19, covid-19, sars-cov-2, coronavirus crisis, coronavirus pandemic, ppe, surgical masks, face masks, FDA regulation, FDA authorization, FDA guidanceComment

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

FDA Guidance Shows a Regulatory Path Forward for Interoperable Devices

FDA Guidance Shows a Regulatory Path Forward for Interoperable Devices

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission.

Regulatory ComplianceNaveen AgarwalApril 2, 2020FDA Guidance, interoperable devices, FDA on interoperable devices, interoperability, medical device innovation, regulatory policy, medical device regulatory policy, premarket guidance, FDA premarket guidance, interoperable medical devicesComment

FDA Guidance Provides Relief for MDR Reporting During a Pandemic

FDA Guidance Provides Relief for MDR Reporting During a Pandemic

Timely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic.

Regulatory ComplianceNaveen AgarwalMarch 22, 2020FDA guidance, MDR, MDR reporting, pandemic, coronavirus crisus, coronavirus pandemic, adverse event reporting, COVID-19, FDA reporting requirements, MDR reporting update, FDA Medical Device Reporting GuidanceComment

How MedTech is Rising to Help Combat the Coronavirus Pandemic

How MedTech is Rising to Help Combat the Coronavirus Pandemic

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA.

Industry NewsNaveen AgarwalMarch 21, 2020COVID-19, coronavirus, coronavirus criss, medtech, coronavirus pandemic, FDA regulation, FDA authorization, FDA approves coronavirus tests, emergency use authorization, SARS-CoV-19Comment

Regulatory Update on Medical Device Cybersecurity

Regulatory Update on Medical Device Cybersecurity

Cybersecurity of medical devices is a rapidly evolving area of concern. Here is an update on recent FDA activities.

Regulatory ComplianceNaveen AgarwalMarch 9, 2020FDA update, cybersecurity update, medical device cybersecurity, SweynTooth, FDA premarket guidance, IMDRF draftComment

How the Medical Industry Can Help Combat the Current Coronavirus Crisis

How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Global outbreak of the recent novel coronavirus needs an all-hands-on-deck approach. Here is how QA/RA professionals in the medical industry can help.

Industry NewsNaveen AgarwalMarch 5, 2020coronavirus, global outbreak, medical industry, medical industry action, coronavirus crisis, SARS-CoV-19, epidemic, FDA, FDA Emergency Use Authorization, EUA, FDA EUAComment

FDA Unlocks the Key to Innovation in Interoperable Medical Devices

FDA Unlocks the Key to Innovation in Interoperable Medical Devices

Interoperability holds the key to interconnected medical devices. A recent De Novo classification of a software for diabetes management shows the way forward.

Industry NewsNaveen AgarwalFebruary 25, 2020FDA News, Interoperable medical device, interoperable medical devices, interoperability, interconnected medical devices, De Novo classification, diabetes management, Internet of Medical Things, IoMTComment

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