If there are particular standards that apply, we specialize in navigating those. We are especially familiar with 80601-2-35 for heating pads, blankets, and mattresses and 60601-2-52 for medical beds.
If there are particular standards that apply, we specialize in navigating those. We are especially familiar with 80601-2-35 for heating pads, blankets, and mattresses and 60601-2-52 for medical beds.
MedRest can facilitate creation of a product risk assessment, in addition to design and manufacturing risk assessments in DFMEA format.
Tell us about your product and we can provide a draft of design inputs, including user needs, design requirements, and requirement tracing.