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

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

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

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

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

5 Key Changes in ISO 14971:2019

The third edition of ISO 14971, just published, aims to clarify requirements and improve effectiveness of medical device risk management.

Regulatory ComplianceNaveen AgarwalJanuary 14, 2020ISO 14971, ISO 14971:2019, Medical Device Risk Management, Understanding ISO 14971:2019, FDA Risk Requirements, Quality Management System, risk management planComment