Our Medical Device Testing & Certification Capabilities »

Our thorough knowledge of industry performance and national safety standards and extensive global testing and certification resources, allows for swift and cost-effective market entry.

  • Product Safety Testing & Certification of Active Medical Devices
  • Electromagnetic Compatibility (EMC) of Active Medical Devices
  • Laser Safety Testing of Medical Laser Products Per IEC 60601-2-22
  • FDA Submissions
  • Battery Safety Testing of all Battery Chemistries used to Power Medical Equipment
  • RFID Susceptibility of Active Medical Devices
  • Certification Body (NCB) & Certification Body Testing Laboratory (CBTL) certification for Medical Electrical products
  • Inspections of high-end medical equipment (e.g. MRI and CT scanners) in hospitals
 

What is Medical Device Testing?

Medical device testing consists of a series of safety and EMC tests which are performed to certify that a product will not suffer from interference in the applicable medical environment and will prevent unacceptable risks to patients.

A risk assessment is also performed by the manufacturer and submitted to a test laboratory in the form of a risk management document. This document provides evidence that a manufacturer has considered all potential hazards and mitigated associated risks to the highest degree possible. The general testing requirements for most electronic medical devices can be found inside the IEC 60601 standard family.