Regulatory requirements for medical equipment

Medical equipment is highly regulated and held to a higher level of safety than nearly all other types of equipment on the market. This is because patients who are not able to respond to hazardous conditions or pain, an actual electrical connection between the equipment and patient may exist, and certain types of medical equipment function as life support, the failure of which could result in the death of the patient. Understanding the certification and regulatory requirements before the design phase of the equipment will result in a cost reduction in equipment development, faster certification turnaround and increased product safety.