The New Quality System Regulation

Satisfying FDA's Quality System Regulation many requirements is demanding and often results in time and cost inefficiencies by manufacturers inexperienced with the QSR.

Sample QSR

The QSR covers many requirements:

  • Quality management and organization
  • Purchase and handling of components
  • Production and process controls
  • Packaging and labeling control
  • Medical device design, evaluation, distribution,
    installation, complaint handling, servicing, and records

The Approach

Trainer

PSE is experienced in helping manufacturers meet QSR requirements.

We tailor a specific guidance path and develop a set of training tools for your staff, via in-house compliance activities or as an outsource contractor based on your needs and requirements.

Training in progress

The Solution

Our medical systems analysis and design support offers direct solutions to challenging applied problems:

  • Determine which QSR controls apply to your design
  • Verify user and patient needs (usability testing)
  • Conduct risk analysis
  • Design Validation
  • Design Verification
  • Facilitate design review process, including design changes
  • Design labeling (usability instructions)
  • Conduct user tests
  • Quality Systems audits
  • Implement a complaint control system
  • Provide training to manufacturing personnel and users

Benefits

PSE can help your company to streamline the QSR approval process by avoiding false starts, dead ends , and other misdirected efforts.