ECG Telemetry
ECG Telemetry
Services Provided
Program / Project Management
Risk Management
Regulatory / Quality
Systems Engineering
Usability Engineering
Mechanical Engineering
Electrical Engineering
Software Engineering
Software Quality
Electrical Product Safety
Client Background:
This medical device client decided to move their project to Concise Engineering after the obsolescence of an off-the-shelf licensed product, to enable the development of their own product.
We inherited the project during the FDA Design Control phase.
Client’s Request(s):
The client requested assistance in managing the device and its development partners to support filing for a 510(k) at the end of the project.
Citing compliance as a key goal, the client also requested that we develop new systems to help them achieve their goals. They also asked us to manage their current outsourced engineering service providers.
Project Actions:
In addition to the services listed above, we also provided a new Quality Management System (QMS), and a document management system, to maintain the necessary controls for maintaining their QMS and DHF-related documents and drawings.
During the project, we provided leadership and expertise to aid the client’s Risk Management and Software Quality departments.
Outcome:
Concise Engineering successfully delivered the following items:
Requirements development, planning, and inputs design review
Successful implementation of new Design QMS
Successful implementation of a new Document Management System