Intertek supports the needs of a Medical Device manufacturer spanning their product life-cycle. From Risk Management to Standards interpretation, through to execution of Testing and Certification – Intertek is your trusted Total Quality Assurance partner.

Respiratory Protection & Face Mask Testing
As a leading provider of respiratory protection device testing, Intertek can assist you with testing requirements and pre-certifications, helping you get your product to market quickly.

Time to market starts with trusted partnership, and for more than 50 years Intertek has been partnering with Medical Device manufacturers globally to provide end-to-end assurance solutions, testing, inspection and certification.

Intertek Assurance and Consulting services provided for medical devices are carried out by a team of Medical Device Experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body and Certification activities.

Regulatory Requirements for Medical Equipment
Bring your medical device to market with a partner who can provide solutions and 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 faster 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.

SPE-3000-15
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.  

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

 
Learn More:
Brexit changes to the European Medical Devices Market
ETSI EN 300 328 V2.2.2 Overview
IEC 60601: Safety Standards for Medical Devices
Medical Device EMC Testing