The previous version of 14155 presented what should be included in a clinical trial but no other guidance, so manufacturers sought it elsewhere. They often used the International Conference on Harmonization Good Clinical Practice, a clinical trials program developed for the testing of pharmaceuticals used in Europe, the United States, Japan and elsewhere.
The new version of 14155 is better aligned with ICH GCP but with key differences that apply only to medical devices. For example, the international standard includes an investigator’s brochure, which is a compilation of clinical and nonclinical data on a product. An investigator’s brochure on a medical device would include the mechanics, software and algorithms, whereas a brochure on a pharmaceutical product would include chemistry and pharmacology.
Read the news release about AAMI’s adoption of international standard 14155.
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