IEC 60601 standard
The international IEC 60601 standard for the safety and performance requirements for electrical medical devices. Does your medical equipment comply with the latest IEC 60601 laws and regulations?
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Medical device certification
Testing & certification
The safety and quality of medical devices must always be paramount. Moreover, innovations are developing rapidly. Medical equipment is increasingly equipped with software and wireless connections. All these developments mean that both medical device manufacturers and testing facilities must meet ever-increasing requirements. We have extensive experience in this field and a vast network of medical experts.
We have all the expertise needed to evaluate, test and certify your medical devices. Our experts are here to support you every step of the way. Whether it’s ensuring your medical facilities and equipment comply with the highest safety standards and regulatory requirements or helping you navigate digital transformation, data protection, and cybersecurity strategies, we’ve got you covered. We provide comprehensive A-to-Z solutions, all from a single source, and tailor them to meet your unique needs and circumstances.
ISO 13485 certification
ISO 13485 is an internationally recognized and harmonized Quality Management System (QMS) standard. It is developed for medical device manufacturers and describes a process approach in terms of the design, safety and quality.
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IVDR
Notified-body medical device certification for in-vitro diagnostic products according to regulatory requirements mandated by European and international norms.
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Medical device regulation
As a medical device manufacturer, you must navigate your way through A complex landscape of regulatory requirements before you can sell your devices on the international market. International standards and European regulations are there to ensure that products are safe and function accordingly.
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Medical Device Regulation (MDR)
Regulatory certification for medical devices subject to the strictest quality, reliability and safety compliance standards to protect public and private health.
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Medical Device Single Audit Program (MDSAP)
Program designed to efficiently provide medical device manufacturers a single audit report and certification recognized across several regulatory jurisdictions.
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Medical electrical device testing
With our global testing labs, we provide comprehensive services for testing electrical and mechanical safety of medical equipment.
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Medical Notified Body HQ Netherlands
Meander 1051
6825 MJ Arnhem
+31 88 96 83009medical.global@dekra.com
DEKRA Certification B.V
Meander 1051
6825 MJ Arnhem
+31 88 968 3560sales.nl@dekra.com
Meander 1051
6825 MJ Arnhem