John Giantsidis Data Security & Privacy Leader. Discussion about GDPR, Cybersecurity, CCPA and Digital Deployment
“Software as a Medical Device” (SaMD) has been defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
What is needed to create and launch an SaMD?
Be able to answer the following questions:
If you have already created a Cyber Incident Response Plan, that is great, please make sure that you have included a step to contact and notify:
EMA published regulatory and procedural guideline: Guidance on remote GCP inspections during the COVID-19 pandemic The guidance covers all phases of remote GCP inspections, with a particular focus on the more challenging aspects, such inspection initiation, feasibility assessment and preparation.