SPE-3000-15 Field Evaluations
Field inspections and labeling of medical electrical equipment (MEE) and medical electrical systems (MES) brought into Canada in limited quantities or one-offs
SPE 3000 sets requirements for the construction, marking and testing for the field evaluation of both MEE and MES. This evaluation is to be conducted by a field evaluation body accredited by the SCC and/or recognized by the regulatory authority.
This code will have a tremendous impact throughout the medical device industry, affecting manufacturers and distributors of medical equipment, doctors, hospitals, medical clinics and others. Thus, it is important for those in the industry to become familiar with the code and its requirements in order to achieve compliance.
To provide guidance on how to ensure compliance with the requirements of SPE-3000, download our white paper which will provide an overview of the model code, its purpose and the steps that must be taken in order to bring medical equipment and systems to the Canadian market.