Driving Regulatory Compliance in Outsourced Product Development
The regulatory landscape for the development of Class II and Class III medical devices is complex. Products must meet rigorous standards such as UL, CE, IEC 60601, IEC 62304, ISO 13485. In addition, development must occur under a quality system with process controls such as those required under Quality System Regulations of Section 21 of the Code of Federal Regulations Part 820 and International Organization for Standards 13485.