In the United States, section 513 of the Federal Food, Drug, and Cosmetic Act sets a risk-based system of three
Summary Artificial intelligence is evolving faster than the regulatory frameworks around it. But that gap is beginning to close, with
For manufacturers based outside the EU, appointing an Authorised Representative for medical devices is an important part of accessing the
Summary CE marking has long been associated with medical devices placed on the European market. As software has increasingly become
Software as a medical device (SaMD) has to meet the same technical documentation obligations as any other device under
Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the
A medical device regulatory strategy sets out, before development gets far, which rules apply to a product, which market approvals
A medical device quality system has to do more than document procedures. It needs to give an organisation a controlled
Summary The MDR and IVDR have significantly changed the regulatory landscape for medical devices in Europe, extending responsibilities and liabilities
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