Healthcare and Medical Device

Expert medical device testing, certification, and healthcare services from DEKRA contribute to safety, regulatory compliance, and quality care worldwide

Healthcare providers and medical device manufacturers operate in a highly regulated and rapidly evolving environment. Rising expectations for patient safety and care quality, increasing digitalization, data protection requirements, and ongoing workforce challenges all add complexity to daily operations.

DEKRA provides a strong foundation for the healthcare and medical device industry through a broad portfolio of independent expert safety, testing, and certification services to contribute to safe, resilient, and future-ready healthcare systems.

DEKRA’s Trusted Approach for Healthcare and Medical Device

Certification

Certification services for medical devices and healthcare systems based on applicable standards and regulatory frameworks.

Expertise

Combining global industry experience and advanced technical knowledge with independent assessment services across healthcare environments.

Cybersecurity

Protecting healthcare systems and connected medical devices from cyber threats, assisting in data protection and secure digital healthcare operations.

Sustainability

Supporting efficient, future-ready healthcare and medical device operations by improving quality, resilience, and responsible use of resources.

Our Approach

With decades of experience, DEKRA is a trusted partner to the healthcare and medical device industry.

We provide independent testing and certification services for healthcare providers and medical device manufacturers. Backed by global experts with extensive industry experience and state-of-the-art technical knowledge, DEKRA delivers assessment services across healthcare environments and medical technologies.

The portfolio includes medical device testing and certification, as well as cybersecurity, training and healthcare-related services. With expertise in innovation, digital technologies and evolving industry requirements, DEKRA contributes to safe, resilient and future-ready healthcare systems worldwide.

Modern operating room with advanced surgical imaging equipment.

Our Featured Services

From medical device testing, to technical dossier review and quality management audits to cybersecurity, and post-market surveillance, DEKRA can serve you throughout the product and service lifecycle. We help ensure patient safety, data protection, and sustainable market access in highly regulated healthcare systems.

FAQ

DEKRA provides testing, certification, and audit services for the healthcare and medical device sector. Our work supports high standards of safety, compliance with applicable regulations, and consistent performance across healthcare settings and medical technologies.

DEKRA provides a comprehensive range of medical device services, including product safety testing, connectivity testing, product certification, and management system assessments throughout the medical device lifecycle.

Product Safety testing is essential to demonstrate compliance with national and international regulations, industry standards, and market requirements.

DEKRA supports product certification by assessing medical devices against relevant international standards and regulatory requirements. This helps manufacturers demonstrate compliance and build trust in their products.

DEKRA helps protect healthcare systems and connected medical devices through cybersecurity assessments, testing, and certification services. This supports secure digital healthcare operations and helps reduce risks related to data protection and system integrity.