ClinIQ Compliance Corner

Quality isn't about passing an inspection. It's about the integrity of the study and the protection of the people who agreed to be part of it. When the conversation turns to ICH E6(R3) and building a culture of quality, the concern I hear most often isn't philosophical. It's practical, and it usually sounds something like this: "We already have SOPs. We have a quality department. I took my GCP training. What else am I supposed to do?" It's a fair question, and the honest answ

ClinIQ's Compliance Corner | May 2026 If you work in medical device clinical research, whether as a sponsor, CRO, monitor, investigator, or site coordinator, ISO 14155 is the international standard that shapes how your clinical investigation should be designed, conducted, and reported. The 2026 edition is now published, and it brings meaningful updates that touch everything from how you define your research question to how you classify adverse events and oversee data quality.