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

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

Understanding Risk Management Requirements in ISO 13485:2016

The current revision of ISO 13485:2016 has new requirements for risk management. Here are some questions to consider and guidance for implementation.

Regulatory ComplianceNaveen AgarwalJanuary 10, 2020ISO 13485:2016, Risk Management, Risk management for medical devices, understanding risk management, quality management system, quality management system for medical devices, risk-based approachComment

How to Avoid a Warning Letter from the FDA

A frequent reason for FDA warning letters is an inadequate corrective action plan to form-483 observations. When it is related to risk management, you need to dig deeper.

Regulatory ComplianceNaveen AgarwalOctober 2, 2019FDA warning letter, FDA guidance, FDA regulation, FDA draft guidance, Risk management for medical devices, form-483Comment