Inspection from regulatory bodies

Inspections from regulatory bodies can be challenging, especially from the FDA.

We can help you with:

  • Assess your Quality Management System’s compliance with ISO 13485 and QSR (21CFR820)
  • Mock inspections for QSR
  • Planning and preparation of different types of FDA inspections, Notified Body audits or inspections from other authorities
  • Communication with the FDA, Notified Bodies, Competent Authorities, etc

Contact me for further information
Nils-Åke Lindberg
Office +46 46 286 88 90 or send me a mail