TEM Consulting International

TEM Consulting is a specialized regulatory and technical services firm primarily serving the medical device and healthcare technology sectors. The company provides deep expertise in electromagnetic compatibility (EMC), wireless technology coexistence, and international regulatory compliance for medical electrical equipment. TEM Consulting is highly active in the development of industry standards, with leadership roles in organizations such as AAMI, IEC, and ISO. Their services include regulatory submission support (e.g., FDA 510(k)), technical testing, and risk management consulting to ensure medical devices meet global safety and performance requirements.