FDA Provides Interim Results of Duodenoscope Reprocessing Studies

The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication

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Are you prepared the new EU MDR Regulations?

What will the new European Union MDR Regulations mean to you?

Quality and regulatory compliance services for the medical device industries. Additional RQS services:

  • Risk Management Resources
  • Access to mechanical/electronic/plastics contract manufacturers
  • Access to marketing resources for labeling
  • Review of labeling and market strategies
  • Resources for IT Management, ERP Implementation & Project Management
  • Reprocessing of Single-Use-Devices (SUD’s)
  • Resources for product development, failure investigation, root cause analysis
  • Resources for all your business development needs
  • Clinical resources: CRO, CRA to assist with clinical evaluations
  • Non-significant risk studies
  • Legal and Regulatory counsel to assist with FDA issues
  • Resources for R&D Innovation
  • Resources for Software Validation

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