Day

December 19, 2019
ISO 14971 Risk Analysis Identifying safety risks in medical devices is a challenging and laborious process.  The process standard, ISO 14971, is a systematic, total product risk management lifecycle process to identify, control, and evaluate risk, where risk is defined as the combination of severity of the harm (to people, property, or environment) and probability...
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I am looking forward to teaching the IEC 62304 Course February 2020 with Brian Pate in Sunnyvale CA. https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 For 15 years I taught the AAMI Software Validation Course with Alan Kusinitz.  These days I have shifted gears to teach the SoftwareCPR 62304 course with Brian Pate. There is a major shift in my perspective between...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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