Intertek supports the needs of a Medical Device manufacturer spanning their product life-cycle

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. Some common medical device categories include:

  • Diagnostic Equipment
  • Surgical Instruments
  • Therapeutic Equipment
  • Monitoring Devices
  • Implantable Medical Devices
  • Dental Devices
  • Assistive Devices
  • In vitro Diagnostic Devices
  • Health Monitoring Devices
  • Home Healthcare Devices
  • Fitness Devices
  • Laboratory Equipment

Intertek's Solutions for Medical Devices

Time to market starts with trusted partnerships, and with the experience of more than 50 years, Intertek has been partnering with manufacturers to provide global Medical Device testing, certification, inspection and assurance solutions.

Medical Industry Outlook and Global Trends
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Testing for 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.

Electrical Medical Devices Testing Solutions

Reach your target markets quickly and cost-effectively with electrical, electromagnetic compatibility (EMC), bluetooth and wireless testing, cybersecurity, software and mobile application testing and certification for your medical device.

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.

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.

Medical Device Testing and Scientific Support Services

Medical device materials testing, chemical analysis and scientific support

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.

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** 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.

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