When participating in a discussion about ISO 14971 with Monir El Azzouzi, I mentioned suggestions about what to study to understand medical device risk management,…
Posts published in “Medical Device Risk Management”
EN ISO 14971:2019 was published today. For those wondering, both the ISO and EN versions were going to be published today, but ISO published the…
Interesting discussion and what I usually see in medical device risk management, unfortunately – a bunch of pretty documents created to “pass the audit” but…
ISO 14971:2019 was published yesterday – see here: https://www.iso.org/standard/72704.html
ISO TC 210 JWG 1 “finished” today the monumental task we’ve been working for the past 3 years – the revision of ISO 14971 and…
The Psychology of Prediction
ISO TC 210 JWG 1 met last week in Stockholm to discuss the last steps of the revision of ISO 14971 and ISO 24971. The…
Um vídeo sobre a reunião em São Paulo do ISO TC 210 IEC SC 62A JWG 1 Aplicação da Gerenciamento de Riscos a Dispositivos Médicos…