Tags¶
cybersecurity¶
- ANSM's Guideline - Cybersecurity of medical devices integrating software during their lifecycle
- Cybersecurity Enhancement Act
- International Medical Device Regulators Forum (IMDRF) *Principles and Practices for Medical Device Cybersecurity*
- International Medical Device Regulators Forum (IMDRF) *Principles and Practices for Medical Device Cybersecurity*
data protection¶
- General Data Protection Regulation (GDPR) *Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data*
- General Data Protection Regulation (GDPR) *Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data*
- General Data Protection Regulation (GDPR) *Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data*
- General Data Protection Regulation (GDPR) *Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data*
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*
- Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*
eu¶
- In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
- In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
fda¶
guidance¶
guideline¶
ivdr¶
- In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
- In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
management¶
manufacturer¶
operator¶
patient safety¶
- International Medical Device Regulators Forum (IMDRF) *Principles and Practices for Medical Device Cybersecurity*
- International Medical Device Regulators Forum (IMDRF) *Principles and Practices for Medical Device Cybersecurity*
post-market¶
privacy¶
- General Data Protection Regulation (GDPR) *Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data*
- General Data Protection Regulation (GDPR) *Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data*
- General Data Protection Regulation (GDPR) *Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data*
- General Data Protection Regulation (GDPR) *Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data*
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*
- Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*