Description: We provide IEC 60601-1 and IEC 61010-1 device testing and regulatory compliance to speed medical devices & laboratory equipment to market.
MECA provides high-quality testing and documentation necessary to show compliance with medical and laboratory equipment standards, primarily related to the IEC 60601-1 and IEC 61010-1 series of standards. Most often, this documentation is used to submit to global regulatory bodies.
MECA is also involved directly in the Standards Development Process as technical experts on various IEC and AAMI standards development committees.
The process of obtaining evidence of compliance to global standards can be difficult, time consuming and frustrating. At MECA, our goal is to help you through this process as efficiently as possible, putting our expertise at your disposal to reduce surprises and resolve issues quickly and effectively. Partner with us for a better experience.