601Plus is a spin-off from AES, an engineering testing laboratory that provided performance, reliability, and competitive testing with customers such as, Sunbeam Products and major Nationally Recognized Testing Laboratories (NRTLs).
Today, our focus is to provide medical device manufacturers and designers clarity, guidance, and compliance design consultancy in meeting the applicable requirements of IEC 60601-1 2nd and 3rd edition series standards for global markets efficiently and cost effectively.
Our specific focus is to provide services that are targeted in meeting the new IEC 60601-1 3rd edition medical electrical equipment standard that is now mandatory in several countries and regions.
We understand the thinking behind IEC 60601-1 3rd edition and it’s this understanding that will provide you with unparalleled service. Allow us to exercise our thorough understanding of IEC 60601-1 3rd edition and apply our expertise in developing your new products and transitioning your legacy products to meet the new 601 requirements.
Company’s Keywords:
medical software, human factors engineering, emc, iec 606011, risk management, product safety, iso 14971, ce marking, medical device consulting, environmental conscious medical design, iso 13485, environmental regulations, fda 510k
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