Roberts Consulting & Engineering

International Medical Device Consultants

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