NEN 7519: Technical Security for Medical Devices
Device Security as a Fundamental Pillar of Patient Safety
As medical devices become increasingly interconnected and integrated into healthcare networks, their security posture directly impacts patient safety and data integrity. Stakeholders, including regulators and healthcare providers, require verified assurance that medical devices are used and maintained in a secure environment.
A NEN 7510-aligned NEN 7519 certificate from Noordbeek validates your organization’s ability to manage the risks associated with medical hardware and software, preventing unauthorized access or malfunctions that could compromise clinical outcomes.
Comprehensive Security Standards for Medical Technology
We provide certification according to the NEN 7519 standard, focusing on the technical and operational safeguards required for the secure use of medical devices throughout their entire lifecycle.
Lifecycle Management
Network Integration
Purpose & Context
Technical Proficiency from Day One
We move beyond the binary “checklist” approach. Our auditors understand the technical nuances of medical hardware, firmware, and complex integration scenarios.
Senior Lead Auditors
Your audit is conducted by professionals who understand the intersection of clinical engineering and IT security. We eliminate the need for client-led orientation regarding medical device environments.
Pragmatic Assessment
We focus on the functional effectiveness of your device controls. Our goal is to ensure your certificate is both reliable and technically substantiated.
Independent Governance
To maintain absolute impartiality, certification decisions are made by our Independent Certification Committee – decoupling the judgment from the field audit team.
Formally Recognized Authority
Noordbeek Certification is an accredited body supervised by the Dutch Accreditation Council (RvA). This oversight ensures that your NEN 7519 certification carries the necessary weight with the IGJ, healthcare insurers, and manufacturers in the medical supply chain.
