Services & Solutions

Quality/Regulatory Compliance (FDA, ISO, EU) Services

• QSR (quality system regulation)
  • Failure investigation
  • Root cause
  • Device master record
  • Quality manual 
  • Procedures
  • Implementation
  • Training
  • FDA 483's
  • Warning letter response
  • Design control 
  • Design review
  • Risk analysis - see also manufacturing risk managment
  • Complaints / MDR
  • CAPA
  • Change control
  • Process improvement
  • Process validations
  • Statistical techniques
  • Reuse
     
• ISO
  • QSR and ISO integration
  • ISO 13485 Quality Systems
  • ISO 14971 Risk Management
  • ISO 11607 Medical Sterile Packaging
  • ISO 11135 Ethylene Oxide Sterilization
  • ISO 11137 Irradiation (Gamma, e-Beam)
  • ISO 10993 Biocompatibility
  • MDD and AIMD compliance
  • Technical file development
  • Process model document
     
• Audit
  • Supplier/Vendor audit
  • Internal audit
     
• 510(k) submission
  • 510(k) writing
  • Labeling compliance
  • IFU
  • Labels