Medical Devices

Keyworld 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 Keyworld has been partnering with manufacturers to provide global Medical Device certification, testing, inspection and assurance solutions.

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.

SPE-3000

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.