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