One important characteristic of developing a solid risk profile is establishing design controls intended to demonstrate that a medical device has been designed to address the needs of users and patients, designed to meet inputs and requirements, proven to meet applicable standards, meets performance criteria. With Design Controls that prove your medical device is safe for use will allow risk management to identify, evaluate, analyze, assess, and mitigate potential product issues according to these. There is a very strong correlation and relationship between Design Controls and Risk Management as they address design, development, and manufacturing of medical devices just from slightly different perspectives. However, it shouldn't be limited to just design controls.

Erbay Dallı, Ö., Ceylan, İ., & Kelebek Girgin, N. (2022). Incidence, characteristics and risk factors of medical device-related pressure injuries: An observational cohort study. Intensive & critical care nursing, 69, 103180. https://doi.org/10.1016/j.iccn.2021.103180

risks can range in many but aren't limited to faulty equipment and other hazards, medical malpractice, and procedures. Managing these and other risks is pivotal within the health care industry to keep people safe and secure, and to keep costs down. Once risk management strategies are put into place, hospitals, long-term care facilities, and other health care organizations can minimize the potential for loss.

This is a very broad question to ask because it depends on the medical device. Generally speaking, in order to look for the critical characteristics of risk profile of the medical device, I will follow ISO 1497:2007 since FDA recognizes it. My primary focus will be the integrated safety design, the protective measures of the medical device, and provide safety information. In my opinion all of what I've mentioned are a priority for the protection of the customer as well as my business.   

An example of a hazard could be an electrical hazard. An electrical hazard can create a hazardous situation if one is exposed to electricity or something along the lines of wires that are connected to a circuit or power cables. An example of a hazardous situation could be cords to a machine that requires electric power that are not properly wrapped. The machine is located in an area where there is a lot of water, facets, and water bottles that are often left behind. A janitor comes by to clean up the area and finds nothing wrong with the area, although they're exposed to an electrical hazard. The janitor leans to clean up the area and finds that they are shocked when trying to clean around the machine.

Below are a few examples, according to the CDC, on how to avoid electrical hazards both in your home and elsewhere:

• Never touch a fallen power line. Call the power company to report fallen power lines.
• Avoid contact with overhead power lines during cleanup and other activities.
• Do not drive through standing water if downed power lines are in the water.
• If a power line falls across your car while you are driving, stay inside the vehicle and continue to drive away from the line. If the engine stalls, do not turn off the ignition. Warn people not to touch the car or the line. Call or ask someone to call the local utility company and emergency services. Do not allow anyone other than emergency personnel to approach your vehicle.
• If electrical circuits and electrical equipment have gotten wet or are in or near water, turn off the power at the main breaker or fuse on the service panel. Do not enter standing water to access the main power switch. Call an electrician to turn it off.
• Never turn power on or off yourself or use an electric tool or appliance while standing in water. Do not turn the power back on until electrical equipment has been inspected by a qualified electrician. All electrical equipment and appliances must be completely dry before returning them to service. Have a certified electrician check these items if there is any question.
• If you see frayed wiring or sparks when you restore power, or if there is an odor of something burning but no visible fire, you should immediately shut off the electrical system at the main circuit breaker.
• Consult your utility company about using electrical equipment, including power generators. Do not connect generators to your home’s electrical circuits without the approved, automatic-interrupt devices. If a generator is on line when electrical service is restored, it can become a major fire hazard and it may endanger line workers helping to restore power in your area.

@keyahbrown these examples highlight the key factors of risk assessment and management of a hazardous device. There are many categories and other areas of design products and risk profile that should be evaluated and taken into consideration. Order and structure of the design matrix should be measured to the level of comparison of its by products and finished product that ensure the business model of the company was best used for its highest level of safety and efficiency for its usage.

Medical devices are classified based on their risk level. The categories are low risk, low to moderate risk, moderate to high risk, and high risk. Multiple factors affect medical device risk classification. One factor is the duration of medical device contact with the body. The degree of invasiveness of the device also plays a role. A third factor is whether the medical device delivers medicinal products or energy to the patient. Another factor is whether the device is intended to have a biological effect on the patient. Another factor worth considering is whether the device effects are local or systemic. These factors help classify the device's risk classification and its risk profile.