This case study illustrates how targeted ISO 13485 support can enable a SaMD and IVD medical device start-up to establish robust, compliant quality systems and achieve audit readiness.
Can you help with our next audit or inspection? Absolutely. Quality Systems Now offers audit readiness reviews, mock inspections, and audit response assistance to support organisations through every stage of the audit lifecycle.
The future of pharmaceutical Quality Management Systems lies at the intersection of regulatory rigor, technological innovation, and organizational excellence.
May 2026 be a year of innovation, regulatory excellence, and continued progress in improving patient outcomes worldwide.