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Manufacturers
Manufacturers
In Vitro Medical Devices
In Vitro Medical Devices
Eu
Eu
In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
Uk
Uk
In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
The security of network and information systems regulations (NIS regulations) 2018
The data protection ACT 2018 (UK GDPR)
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
Norway
Norway
In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
NORMEN: *Code of conduct for information security and data protection in the healthcare and care services sector*
Us
Us
The Food, Drug, and Cosmetic Act (FD&C Act)
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions *Guidance for Industry and Food and Drug Administration Staff*
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software *Guidance for Industry*
Device Advice: Comprehensive Regulatory Assistance
Medical Devices
Medical Devices
Eu
Eu
Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
Uk
Uk
Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
The security of network and information systems regulations (NIS regulations) 2018
The data protection Act 2018 (UK GDPR)
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
Norway
Norway
Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
NORMEN: *Code of conduct for information security and data protection in the healthcare and care services sector*
Us
Us
The Food, Drug, and Cosmetic Act (FD&C Act)
The Health Insurance Portability and Accountability Act (HIPAA)
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions *Guidance for Industry and Food and Drug Administration Staff*
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software *Guidance for Industry*
Device Advice: Comprehensive Regulatory Assistance
Classification of medical devices
Classification of medical devices
Classification of medical devices
MDCG 2021-24 *Guidance on classification of medical devices*
Medical device classification - FDA overview
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] *Guidance for Industry and Food and Drug Administration Staff*
Operators
Operators
In Vitro Medical Devices
In Vitro Medical Devices
Eu
Eu
In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
European action plan on the cybersecurity of hospitals and healthcare providers
Uk
Uk
In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
The security of network and information systems regulations (NIS regulations) 2018
The data protection ACT 2018 (UK GDPR)
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
Norway
Norway
In Vitro Diagnostic Device Regulation (IVDR) *Regulation (EU) 2017/746 on in vitro diagnostic medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
NORMEN: *Code of conduct for information security and data protection in the healthcare and care services sector*
Us
Us
The Food, Drug, and Cosmetic Act (FD&C Act)
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
Device Advice: Comprehensive Regulatory Assistance
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software *Guidance for Industry*
International Medical Device Regulators Forum (IMDRF) *Principles and Practices for Medical Device Cybersecurity*
Medical Devices
Medical Devices
Eu
Eu
Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
European action plan on the cybersecurity of hospitals and healthcare providers
Uk
Uk
Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
The security of network and information systems regulations (NIS regulations) 2018
The data protection Act 2018 (UK GDPR)
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
Norway
Norway
Medical Device Regulation (MDR) *Regulation (EU) 2017/745 on medical devices*
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*
The Cyber Resilience Act (CRA) *Regulation 2024/2847 on horizontal cybersecurity requirements for products with digital elements*
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
MDCG 2019-16 *Medical Device Coordination Group: Guidance on Cybersecurity for medical devices*
NORMEN: *Code of conduct for information security and data protection in the healthcare and care services sector*
Us
Us
The Food, Drug, and Cosmetic Act (FD&C Act)
The Health Insurance Portability and Accountability Act (HIPAA)
ISO 13485:2016 *Medical devices — Quality management systems — Requirements for regulatory purposes*
Iso 14971
ISO/IEC 27001:2022 *Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements*
ISO/IEC 27701:2019 *Security techniques*
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions *Guidance for Industry and Food and Drug Administration Staff*
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software *Guidance for Industry*
International Medical Device Regulators Forum (IMDRF) *Principles and Practices for Medical Device Cybersecurity*
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