USA

We can help you with:

  • Assessing and updating your quality management system compliance to QSR (21 CFR 820)
  • 510(k), De Novo and PMA submission
  • Communication with the FDA
  • FDA mock audits

Contact me for further information
Nils-Åke Lindberg
Office +46 8 621 01 05 or send me an e-mail