Program and DHF Management – REM

Ensure Completion of Design Control Deliverables Across Enterprise Regulated Value Streams

Project and DHF Manager manages new product development design projects, activities and content with creation of the device design history file to satisfy regulatory standards and good manufacturing practices for design control.



All companies are faced with ever-shrinking product lifecycles in order to timely satisfy the diverging needs of global markets. This has resulted in an increase number of concurrent product development programs, which necessitates adoption of concurrent engineering methods. However, this also increases complexity due to the parallel activity of various functional teams. Coordinating the various functional teams to prevent overloaded resources and bottlenecks is critical for optimizing cycle time.  This becomes even more challenging in industries that demand product development to comply with government regulations.

Project and DHF Manager uniquely accomplishes zero delays by linking product development data to design project execution. In effect, design project management becomes data-driven by being linked with the product portfolio and the design content that regulatory agencies demand. When the two processes are disconnected with different technologies, there are multiple design projects being tracked, but they are not grounded in the reality of the product data that is created.  Additionally, with disconnected processes it is not clear if the design content needed for regulatory agencies is being produced to ensure an on-time product launch.

Project and DHF Manager dramatically increases productivity globally by executing design projects and programs with real-time design information updates via automated synchronization of design artifacts to the DHF. This automated synchronization allows the design project or program manager to focus on high-value activities rather than tracking down design status.  With Project and DHF Manager, companies can provide global teams with the accurate, real-time design information they need to keep design projects on track in response to ever-shrinking product lifecycles. Project and DHF Manager provides management with real-time visibility into a design project’s status in terms of overall schedule, phases, gates, and resources.

Project and DHF Manager is implemented in the medical device industry, which places a priority on design quality. Poor design quality can literally be a matter of life and death in its worst case. Because of the risks involved in the development of novel medical devices, due diligence is of the upmost importance in terms of quality control measures. These competing priorities—quality and time-to-market— must be well managed through a careful process in order to reduce the risks inherent in the medical device industry.

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