The future of Privacy and Cybersecurity for Medical Devices Software and SaMD

Mr. Radharamanan Hariharan

  • Current Challenges 
  • PHI and HIPAA context
  • FDA, GDPR, HIPAA & ISO requirements
  • Privacy & Security by Design and by default
  • C,I, A & Risk Assessment
  • Next steps to ensure compliance

Having over 30 years of experience in the Medical Device Industry, Rad is the Founder of Maruthi Quality Management Services (MQMS), www.maruthiquality.com.

Rad gained his experience at companies such as: Robert Bosch, Infosys Technologies, and Philips, before founding MQMS.

Rad is a Six Sigma Black Belt and an expert in Medical Device software processes. He is a lead auditor for ISO 13485, ISO 27001 and ISO 27701, and  an implementation specialist for HIPAA privacy, security  and GDPR

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