Our Medical Device Testing & Certification capabilities »
- Product safety compliance in the United States and Canada
- Medical EMC compliance
- Medical Device Battery Safety Testing
- Medical Devices for RFID Susceptibility
- Electrical wheelchairs to ANSI/RESNA/FDA/EN requirements
- FDA Guidance Documents and consensus standards necessary for FDA clearance, including IEC 60601, AAMI and ASTM standards.
- Inspections of high-end medical equipment (e.g. MRI and CT scanners) in hospitals
MET is a National Certification Body (NCB) and a Certification Body Testing Laboratory (CBTL) under the international certification body scheme, or CB scheme, for Medical Electrical products. Our test reports and certificates are recognized by over 50 countries.
Medical Device Notified Body Certification
MET works closely with a Notified Body to assist clients with the requirements of the Medical Device Directive 93/42/ECC. We have the expertise necessary to speed your product into the European market in a timely manner.
Medical Device Performance Testing
As an independent, third-party testing laboratory, MET puts its substantial skills and resources to work in the performance and comparative testing of your medical device. MET provides:
- Full range of performance testing including functionality, energy efficiency, durability, reliability, and more
- Full range of performance tests to many FDA Guidance Documents, AAMI and ANSI standards
- Special tests to establish and/or validate claims on new medical devices
- Unique testing facilities for many special medical devices including: electro-surgical devices, ultrasound equipment, electric wheelchairs and many more
- Litigation support testing, expert witness
Advantages of using Eurofins | MET Labs
- 24 hour start for critical projects
- Real-time on-line project tracking
- Extensive knowledge of FDA requirements and procedures
- Less than one hour drive from FDA headquarters, for conducting face-to-face meetings and helping to expedite a clearance
MET’s thorough knowledge of industry performance and national safety standards, combined with extensive global testing and certification resources, allows you to get your product on the market in a timely and cost-effective way.
What is Medical Device Testing?
Medical Device testing evaluates a medical product’s performance and safety to ensure safety for patients and operators, while simultaneously evaluating the cost-benefit of existing hazards and potential benefits. Medical Device testing consists of a series of safety and EMC tests are performed to prove 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 manufacturers 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.