Logic's dedicated Medical Practice Team is highly experienced in the technologies, processes, and regulations that are important in developing and manufacturing medical devices.

Foremost in the Practice team's responsibilities has been establishing the tools and process infrastructure necessary for the medical product marketplace, and training of our staff on effective development using FDA-mandated design controls and risk management practices.

• Our devoted Medical Practice Team creates smart and innovative medical solutions that are straightforward, easy to use and intuitive.

• We specialize in creating FDA Class I, II, and III medical device solutions.  40% of Logic's services business is in development of medical devices.

• Our experience with FDA guidance documentation and 510(k) approvals assures that standards are met, and that project headaches are avoided, such as last-minute design or documentation changes to address regulatory concerns.

• Our design and manufacturing teams are ISO13485 certified.   

Tools:

• Jira issue tracking system

• Provides a record of process and diligence in design

• Controls ECO workflow

• SVN revision control system

• Tracks changes to system design artifacts

• Oracle Agile document control

• Ensures correct approval and access to latest documents

• Medical Standards (ISO, IEC, AMI, etc.)

• Ensure that we meet internationally-recognized standards of excellence in safety, process and performance.