Training on the requirements of the EU MDR/IVDR, including practical implementation and maintenance of quality management systems according to ISO 13485, including MDSAP.
Assistance with establishing branches or companies in the EU to
enable them to act as their own EU REP.
Consulting and
support for setting up manufacturing facilities within the EU.
Rectification and successful completion of previously unsuccessful
regulatory submissions.
Assistance for companies that have
been dropped by their consultants or Notified Bodies, aimed at
restoring compliance and progressing through the regulatory
process.