Medical Device Assurance, Testing, Certification & Auditing
Intertek supports the needs of a Medical Device manufacturer spanning their product life-cycle.
Time to market starts with trusted partnership, and for more than 50 years Intertek has been partnering with Medical Device manufacturers globally to provide testing, inspection and certification.
Regulatory Requirements for Medical Equipment
Bring your Medical Device to market with a partner who can navigate Regulatory Requirements for IEC 60601-1, IEC 60601-1-2, MDR, IVDD, and the CB Scheme.
Medical Devices Testing Solutions
Reach your target markets quickly and cost-effectively with Electrical, Electromagnetic Compatability (EMC), Bluetooth and Wireless Testing, Cyber Security, Software and Mobile Application testing and certification for your medical device.
Environmental & Regulatory Services
We fully support the medical device industry to comply with changing global Health and Environmental regulatory requirements and restrictions, such as RoHS, REACH and WEEE.
Medical Management Systems Certification & Auditing
From ISO 13485 to MDSAP, get to market with integrated compliance solutions and a committed, global auditing support network on your side.
Scientific Support Services
Medical device and materials testing including safety assessment through Extractables and 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.
For Medical Products entering the Canadian Market, 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.
*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.