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The European Medical Device Regulation (MDR 2017/745) [10] and the medical EMC collateral standard (IEC 60601-1-2) [13] are built on a legal foundation that specifies a risk-based approach, as outlined by the risk management standard ISO14971. [14] The ISO14971 risk-based EMC approach has also been incorporated into the ETERNITY project. [12]
Regulatory risk differentiation is also referred to as the Compliance Model in some regulatory agencies. [1] See for example the Australian Prudential Regulatory Authority risk differentiation approach known as: PAIRS [2] / SOARS. [3] PAIRS is the Probability And Impact Rating System, while SOARS is the Supervisory Oversight And Response System.
In this context, risk-based regulation refers to the approach of identifying and assessing potential risks of money laundering and terrorist financing and implementing regulatory measures proportional to those risks. However, the shared enforcement powers between EU and national authorities in the implementation and enforcement of AML/CFT ...
Basel III requires banks to have a minimum CET1 ratio (Common Tier 1 capital divided by risk-weighted assets (RWAs)) at all times of: . 4.5%; Plus: A mandatory "capital conservation buffer" or "stress capital buffer requirement", equivalent to at least 2.5% of risk-weighted assets, but could be higher based on results from stress tests, as determined by national regulators.
The Risk Management Framework (RMF) is a United States federal government guideline, standard, and process for managing risk to help secure information systems (computers and networks). The RMF was developed by the National Institute of Standards and Technology (NIST), and provides a structured process that integrates information security ...
By December 2023, the Ministry of Innovation and the Ministry of Justice published a joint AI regulation and ethics policy paper, outlining several AI ethical principles and a set of recommendations including opting for sector-based regulation, a risk-based approach, preference for "soft" regulatory tools and maintaining consistency with ...
Risk-weight functions - Functions provided as part of the Basel II regulatory framework, which maps the risk parameters above to risk-weighted assets; Minimum requirements - Core minimum standards that a bank must satisfy to use the internal ratings-based approach; The accord provides two broad approaches that a bank can follow: [5] Foundation ...
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.