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ISO 14155 2011.pdf

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Regarding applicability of ISO 14155 to post-market clinical studies, it is understood that sponsors must ensure that post-market clinical studies meet the provisions of the MDR and the principles of good clinical practice, and that such studies may only be conducted and reported in compliance with ISO 14155:2011. However, there is no guidance as to what changes in the requirements of the standard are necessary for post-market clinical trials (such as those made by the revisions of Annex XV).

ISMP 14155:2011 states that sponsors are responsible for clinical quality assurance and quality control and that in the case of studies involving sensitive or potentially serious adverse events, sponsors should seek a certification of clinical trial accreditation by the CCME. However, only the latter is the topic of the draft version of ISO 14155:2018. Annex I of the draft ISO 14155 describes the clinical development stages of medical devices and the applicability of ISO 14155 to every specific stage of medical device development. In addition, Annex I of the draft 14155 (which is expected to be finalized by the time that this Draft ISO 14155:2018 is published) clarifies that the standards requirements related to clinical investigations apply to both investigative and manufacturing sites, and clarify that sponsor needs to ensure that investigators and manufacturing sites are certified to the ISO 14155 requirements. Thus, it will be interesting to see what (if anything) this Draft ISO 14155:2018 will mean for sponsor clinical investigators and manufacturers.

Thanks for the website! It is very helpful. I have a question about patient studies. Do you think any companies are obligated to apply ISO 14155:2011 or should it be left to the discretion of individual companies? 84d34552a1