NEN 7519: Technical Security for Medical Devices
Establish a sound basis for patient safety with senior-led certification focused on the secure deployment and management of medical devices.
Device Security as a 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.
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 Device Security Standards
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
We evaluate the security measures applied from procurement and installation to maintenance and decommissioning of medical devices.
Network Integration
Our audit assesses the technical controls used to isolate and protect medical devices within the healthcare IT infrastructure.
Purpose & Context
We verify the alignment between medical device security and your broader NEN 7510 information security management system, ensuring a unified approach to risk mitigation.
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.
The Certification Roadmap
01
Scope Alignment
Defining the technical inventory and organizational processes covered by the device security framework.
02
Stage 1 Audit
Reviewing device-specific documentation and assessing readiness for the full operational evaluation.
03
Stage 2 Audit
A deep technical dive into the effectiveness of hardware security, patch management, and network isolation.
04
Independent Review
Final decision by the Certification Committee to award the NEN 7519 certificate.