Calls For More Patient Input In Medical Device Development And Regulation
It is vital to involve patients in medical device development, regulatory assessments, and post-marketing activities. The European Patients’ Academy on Therapeutic Innovation (EUPATI) has explained why and what it is doing to drive progress.
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While recently proposed amendments to the draft EU legislation on Artificial Intelligence are a step in the right direction for medical devices, trade associations MedTech Europe and COCIR warn that the potential for regulatory conflicts remains.
Hybrid audits of quality management systems (QMS) can satisfy certain requirements of new EU medtech regulations while improving efficiencies, TEAM-NB has said. In a new position paper, the association details how and when hybrid audits are appropriate.