Product Quality teams in life sciences face rising scrutiny, shifting from record-keeping to efficiency and compliance drivers. Leaders are turning to AI-powered quality management systems (QMS) to deliver insights, automate workflows, and predict risks. Pharma and MedTech align on patient safety but differ in operational execution due to scale and product mechanisms. Both must navigate evolving global regulations, focusing on safety and efficacy across design, manufacturing, distribution, and monitoring. Regulatory submissions hinge on four principles: proven safety and performance, adherence to good practices, third-party pre-market review, and robust post-market vigilance.

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