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