Comprehensive Testing, Certification and Assurance for Medical Devices

Intertek supports Medical Device manufacturers in meeting all Safety and Quality requirements around the world

Medical devices encompass a broad range of instruments, apparatuses, machines, implants, or other similar articles intended for use in the diagnosis, treatment, monitoring, and/or prevention of illnesses and diseases. They can vary widely in complexity and purpose. With more than 50 years of experience, Intertek has been partnering with manufacturers to provide Medical Device testing, certification, inspection and assurance solutions, decreasing time to markets around the globe.

Intertek's Solutions for Medical Devices

Medical Equipment Regulatory Requirements

Global Regulatory Requirements - 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.

Safety Solutions for Medical Devices

Intertek offers Safety Testing solutions for Medical Devices enabling you to demonstrate compliance to Electrical Safety, EMC and Performance Standards in global markets.

FDA ASCA Program

The FDA's ASCA Program is aimed at ensuring quality and accuracy in medical device pre-market submissions. Ultimately the goal is to help make the process more efficient and to add confidence in the levels of safety, performance, and quality assurance.

Intertek Assuris

Our global network of scientists, engineers, and regulatory specialists provide support to navigate complex scientific, regulatory, environmental, health, safety, and quality challenges throughout the value chain.

hand wearing white glove picking up a pair of medical scissors

Medical Devices Auditing and Certification Services

The medical device industry faces specific challenges when bringing their products to the global market with strict and complex global regulations. Our Auditing and Certification Services offer a unique combination of in-depth knowledge and global presence.

partial view of upper part of a patient lying in a hospital bed covered with a yellow blanket with tubing from a breathing assistance device just showing on the right hand side

Medical Device Testing and Scientific Support Services

Medical device materials testing, chemical analysis and scientific support

Dermatologist providing thermage treatment to woman's forehead

Clinical Studies

Multi-disciplined clinical teams who provide robust, GCP and ISO 14155 compliant clinical trials

SPE-3000: Medical Field Evaluations

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.