AUDITORS’ ORATORY: what challenges do drug/device combinations bring to notified bodies and manufacturers?
This article was originally published in Clinica
Drug/device combinations present particular challenges for notified bodies and this can be a deterrent for some. . Amanda Maxwell spoke with Theresa Jeary, technical manager for medical devices at UK notified body Lloyds Register Quality Assurance, to ascertain what these challenges are, including those related to recruitment and training of notified bodies, and finds out what it takes to work in this area
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