Case Study: Development Planning

A medium-size manufacturer of medical devices, realizing that they were not in compliance with the development planning section of the design control regulation at one of their locations, needed to put development plans in place for their current development projects.

AlvaMed developed a comprehensive approach to planning that simplified the process by appropriately referencing the company's existing design control SOPs to the greatest extent possible. Maximum flexibility was maintained by changing the quality system to permit a development plan to modify or even supersede a quality system SOP when warranted. This required putting adequate safeguards in place to ensure that quality system SOPs were not superseded in appropriately. This approach struck an optimal balance between simplifying the content of development plans in those areas that are to follow standard quality system SOPs while adding detail only for those aspects of the plans that are unique to the particular project.

The approach has been successfully used at a number of companies, some of which have subsequently undergone successful FDA design control audits.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control