The risk management process does much more than determining compliance to the 3rd edition. The introduction to the standard states that “in all cases, the risk management process will determine whether the requirements of the standard are acceptable and appropriate”. Therefore the risk management process established by the manufacturer allows it a new freedom. Based on risk management the manufacturer is allowed to tailor the requirements of the standard to the needs of the device, rather than adjusting the device design to the requirements of the standard. The 2nd edition did not allow this freedom. This allows for new techniques or technologies to be used in a design if they have been proven safe by the risk management process even if they were not specifically called out in the standard.