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