Medical Device Problem Solving Consulting

Perform tasks and operations where there is a personnel/skills gap in the organization until that gap can be closed. You can rest assured knowing that these tasks are performed competently, compliantly, and completely.
Examples:

· Process validation including creation of overall strategy & IQ/OQ/PQ completion.

· Failure investigation, CAPA plan and execution

· Develop & implement costs savings for products & processes

We can lead your next quality system improvement, product improvement, or cost reduction project using project management skills and a practical, collaborative approach to ensure your business meets its objectives. We can continue to do so even after the project is completed. Raymond P. Solutions, Inc. can provide simple, sustainable strategies to minimize immediate and long-term impacts while delivering enhanced safety, compliance, and/or quality. Examples:

· Streamlining & improvements to validation & CAPA processes.

· Value Engineering & Design for Manufacturability reviews

Where there are quality system gaps or issues, we can fill those with procedures, processes, and personnel training to re-mediate those gaps. In addition, we can create and perform competency assessments so that you and your organization KNOW you are meeting your objectives.

· Ensure Production and Process controls, Purchasing Controls and Design Controls are effectively utilizing Risk based systems

· Develop new or Improved Master Validation Plans

· Create a training curriculum for failure investigation and CAPA; train cross-functional personnel on risk management.