Take QAI’s expert advice to get your Medical Electrical Equipment tested and approved under the SPE-3000 code
Special Inspection Service SPE-3000 was developed to address the need for an evaluation of electrical safety of Medical Equipment and Medical Electrical Systems. Equipment in compliance with the requirements and bearing the Special Inspection Service label is considered to be acceptable to the AHJ.
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.
The importance of this standard to the medical industry is enormous and allows manufacturers, distributors, hospitals, and medical clinics the ability to get their product approved efficiently at an affordable rate.
QAI Laboratories is a Standards Council Of Canada (SCC) Inspection Body accredited to perform these approvals that is recognized by the Authorities Having Jurisdiction (AHJ’s) Across Canada.
Has your medical equipment already been shipped or installed without Certification or approval? Do you need an efficient turnaround time to get your product approved?
Feel free to contact us: email@example.com
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