Read our White Paper Design Changes: the Management of Changes before and after a 510(k) Notification and get further information on:

  • what is a Design Change;
  • when notifying a Design Change to the FDA;
  • when submitting a 510(k) Notification for a Software Change.

Fill in the form to receive by email your White Paper!

    Name and Surname



    Consent to processing of data
    in accordance with D. Lgs. 196/2003 adapted to the GDPR 679/16 EU by the D.Lgs. 101/2018, I agree to receive the CONTENT referred to in question and receive the periodic NEWSLETTER INFORMATION Thema S.r.l
    Information concerning the processing of personal data