Clinical investigations for medical devices Clinical trials using medical devices are called clinical investigations, and the purpose of a clinical investigation is to answer important scientific questions. It must follow strict scientific standards (such as the ISO 14155 standard) which…
The first thing one needs when working with quality management, as with numerous other areas within and outside the medical device industry, is their own copy of the standard. ISO 13485:2016 is the Medical devices – Quality management systems standard and it…
Compliance with industry regulations and standards is a fundamental part of Medtech. Without proper medical device compliance, companies risk harming patients, litigation, and reputational damage. Fortunately, compliance with medical device regulations and standards is not an impossible task. A company-wide…
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