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

•    Regulatory Requirements for Medical Equipment include IEC 60601-1, IEC 60601-1-2, Medical Devices Directive (MDD), Medical Device Regulation (MDR), IVDD, and the CB Scheme.

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

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

•    Get to market faster with integrated compliance solutions and a committed, global team on your side.

•    Medical device and materials testing including safety assessment through extractables and bioanalysis supporting all stages of development and manufacturing.

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