Regulators

A view along a boardroom tableThe regulatory framework for new surgical devices is currently less well defined than for drugs, and that for new operations and techniques even less so.

Regulators need valid evidence to make judgements about risk, but also need to avoid slowing and inhibiting innovation more than absolutely necessary.

IDEAL provides a rational framework for the types of evidence which can reasonably demanded at each stage of the development of new techniques and devices.

This framework can be used to derive principles for regulatory requirements

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