Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

For years, the medical device industry has been expecting the alignment of FDA’s 21 CFR Part 820 quality system regulation (QSR) with the international ISO 13485 standard. FDA issued a proposed rule ...

The main market opportunity lies in providing practical, inspection-ready training for batch record review tailored to pharma, biologics, and medical device fields. By focusing on real-world ...