Medical

 

Professional Testing can navigate the growing worldwide FDA 510(k) EMC medical requirements of IEC 60601-1-2.

Coupled with our Product Safety/NRTL approvals, PTI becomes your one-stop service provider to bring your medical product to market. The EMC requirements are similar to those described on our Commercial EMC Services page, but incorporate more stringent limits and criteria. This provides additional protection to medical patients and the sensitive equipment utilized in hospitals and healthcare facilities. Along with these evaluations, PTI can start by developing the Risk and Hazard Analysis for your new product.

Standard Description
UL 60601 Medical Equipment
IEC 14971 Application of Risk Management to Medical Devices
*CDRH 21, CFR Laser Products
UL XXXX Although we specialize in the above standards, there are many more we can evaluate product to, just ask.

*Laser Products
The Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA), regulates laser products imported to or manufactured in the United States.  When submitting a product containing a laser through an NRTL for use in the United States or Canada, it may be necessary to evaluate your product for laser safety in accordance with CDRH 21, CFR or CSA E60825 respectively.  PTI can evaluate your product to CDRH 21, CFR or CSA E60825 and assist you with the required documentation for compliance with these standards.

Why Choose PTI?

We help our customers be proactive by getting involved early in the design phase, designing in reliability and compliance. The result is bringing products to market faster with less cost, and better service.  Learn More >

Contact Us

  • Toll Free:
  • Phone:
  • Fax:
  • Email:
тренинговый центр открытый мир норбеков отзывы тренинговый центр роза мира синельников форум кинезиология форум синтон школа звезд олег гадецкий сайт о сектах Лидер класс спасение близких от культов психокульты куба отзывы onetwotrip отзывы форум по турции форум египет тур форум испания отзывы туристов тайланд достопримечательности китая отзывы об отдыхе отзывы об отелях турции Отдых в Нячанге Отдых в Малазии roboforex reviews roboforex roboforex reviews roboforex roboforex reviews roboforex reviews roboforex roboforex reviews