Medical Device Testing, Certification & Auditing

From standards interpretation to risk management, testing and certification, Intertek has you covered.

Get your medical device tested and into the hands of your customers faster than ever before. Time to market starts with partnership, and for more than 50 years Intertek has been partnering with medical device manufacturers to develop global regulatory solutions for device testing, certification and auditing.

Intertek consulting services provided for medical devices are carried out by medical device experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body activities.

Regulatory Requirements for Medical Equipment
Bring your medical device to market with a partner who can help you navigate regulatory requirements for IEC 60601-1, IEC 60601-1-2, MDD, IVDD, and the CB Scheme.

Medical Product Testing Solutions
Reach your target markets quickly and cost-effectively with electrical, software and mobile application testing and certification for your medical device.

Environmental & Regulatory Services
We fully support the medical device industry to comply with global health and environmental regulatory requirements and restrictions, such as RoHS.

Medical Management Systems Certification & Auditing
Get to market faster with integrated compliance solutions and a committed, global team on your side.

Scientific Support Services
Medical device and materials testing including safety assessment through extractables / leachables and bioanalysis supporting all stages of development and manufacturing.

Clinical Research Services
Multi-disciplined clinical teams who provide robust, GCP and ISO 14155 compliant clinical trials for low risk medical devices.

SPE-3000
Serves as the model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES), specifically pertaining to safety from electric shock, fire and mechanical hazards. 

Auditing and Systems Certification

 

*Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.

 

Need help or have a question?

+1 800 967 5352
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+44 1372 370900
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+55 11 2842 0444
APAC:
+86 400 886 9926
EMEA:
+46 8 750 0000
Germany
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UAE
+971 4 317 8777