Quality Assurance Services 

The areas in which we can make a difference include:

  • Development and implementation of Quality Systems (ISO 13485, QSR - 21 CFR 820 & CMDCAS)
  • GAP analysis: monitoring and modification of QMS
  • Risk management and risk analysis of medical devices - ISO 14971
  • Preparation of SOPs

Further information regarding services, expertise and how our experience can support your business; please contact us at +4526709648, Email: info@slet-dette.toxregulatoryaffairs.com