The medical industry is rapidly adopting new technology that enables better communication and performance of products & systems to improve the safety of care. Manufacturers today, face a number of compliance challenges, as devices that do not meet the highest quality and safety standards present, a risk of injury, recalls, bans and liability.
Electronic devices used in medical environments have important safety and performance requirements to ensure safety and compatibility with other critical care equipment.
MET is a one-stop-shop for EMC and safety testing for medical devices to verify compliance with major standards and international regulations.
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
Additional advantages to using MET Laboratories:
- 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.
Product: Phoenix Arm Monitor
Standard: UL 60601-1 & C22.2 No.601-1 Medical Electrical Equipment, Part 1
Sold at: Costco, CVS, Target, Best Buy, Brookstone
Some of MET’s other Medical Device Testing customers:
“I would like to thank everyone for accommodating the testing of our product and working tirelessly to meet a very tight schedule. We are very happy with the work. Please pass our sincere appreciation to all of your associates who worked tirelessly to help us meet the tight timeframe.”
Virginia Njagi, Project Lead, EE
Dilon Technologies, Inc.