Get free white papers and learn from industry experts about how ISO 13485 provides a framework for medical device compliance internationally. The primary goal of the ISO 13485 standard is to provide a harmonized model for the medtech industry to meet quality requirements in a global market.
ISO 13485 compliance helps ensure that companies will meet the FDA's requirements for 21 CFR Part 820 for quality system regulations.
Compliance with ISO 13485 is often seen as the first step in complying with European regulatory standards.
ISO 13485 helps companies maintain efficient and holistic quality management processes and reflects a strong commitment to continuous improvement.
ISO 13485:2016 has quickly become the global standard for medical device quality requirements. A comprehensive ISO 13485 overview will help your company meet the standard faster and more cost effectively.
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