Good Design Practice for Medical Devices and Equipment : A Framework

The objective of this workbook is to help people design medical devices and equipment that are easier and more economical to validate.

The book has been developed to satisfy an industry need for guidance to support concurrent design development and validation.

Regulation in the European Union and the United States has developed significantly during the last 20 years, moving from a manufacturing process focus to a device design and manufacturing process focus.

This is driving the medical device industry to take a more concurrent and integrated approach to design, development and validation.

In particular, elements such as design control, which is referred to globally in standards and regulations, require that more attention be focused on the design and validation programme in order to ensure that the device and its associated manufacturing and test equipment are reliable and fit for purpose.

Regulations and standards usually specify what evidence is necessary to meet the new medical device requirements, but rarely provide useful guidance on how to produce the evidence. The methods and guidance industry needs to address concurrent design, development and validation requirements should be covered by good design practice, which includes concepts such as design for manufacture and process validation guidance, but it falls short of the real target.

Current good design practice needs to be extended to include design for validation to prompt designers to consider validation during the design of both the device and its related equipment.