IMC accelerates the development process and increases value through structured project records, product requirements, and risk management.

IMC   SOLUTIONS: Medical Design Control Systems

Design & Regulatory Documents
Risk Management

Create streamlined product development  systems pinpoints documents and meet medical device regulations.  Examples include:

  • Requirements

  • Risk and Hazard Analysis

  • Document Management

  • Usability

Documenting, mitigating, and eliminating risk achieves rapid time to market, saves resources, complies with regulations, and adds value.

 

IMC works with the client to:

  • Facilitate Risk and Hazard Analysis

  • Construct required risk management plans

  • Suggest risk elimination actions

  • Project Plan and Schedule

Clear Arrow
Structured Development Records

Structured development records are vital.

 

 

IMC creates customized FDA Quality System document structures that:

  • Prevent wasted time and resources

  • Comply with FDA regulations

  • Provide clear and timely information for Agile teams.