Regulatory Whitepaper Download

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.

This whitepaper discusses some of the key regulatory requirements that must be met to successfully deliver a medical device to market, including

• IEC 60601: Safety and Essential Performance of Medical Electrical Equipment

• ISO 14971: Managing Risk in Medical Device Product Development

• IEC 62304: Medical Device Software Lifecycle Processes

• ISO 13485: Quality Management

Provide your details in the form on the left and you will receive a copy of the whitepaper via email