Medical Device and IVD Consulting

Services Provided

  • ISO 13485:2003 / ISO 9001:2000 Implementation and Training
  • MDD / IVDD CE marking / Design Dossiers
  • Sterilization / Biocompatibility
  • 510 (k) / PMA / Canadian Device Licenses
  • Supplier and Internal Audits
  • Expert Witness

Contact:

Mark Roberts Mroberts@robertsce.com

Roberts Consulting & Engineering

1042 N. El Camino Real, Suite B233
Encinitas, CA 92024 USA

ph: 619 405 5717 FAX: 760 942 0492

About RCE
Our associates have worked for leading device companies, Notified Bodies and ISO Registrars. We provide support to companies ranging from a 2 person start up to leading members of the Fortune 500