Regulatory

Quality Management System

• ISO 13485 quality system certification (PDF, 0.5M)

Good Manufacturing Practice (GMP)

• EUROPE: GMP as laid down in Commission Directives 91/356/EEC, and as amended by Directives 2003/94/EC and 91/412/EEC respectively.
• UNITED STATES: Fully compliant with 21 CFR part 820, US FDA Quality Systems Regulations

Product Certifications and Approvals

• CE Mark Certification (PDF, 0.5M)
• UNITED STATES: We are awaiting FDA 510(k) clearance

Global Regulatory Representatives

Shown below are our in-country representatives for regulatory affairs issues and incident reporting.

• EUROPE - Ann Savell, Director of Operations
  Orthomimetics Ltd, Byron House, Cambridge Businesss Park, Cambridge CB4 0WZ
  Tel: +44 (0)1223 437470
  Fax: +44 (0)1223 437471
  Email: admin@orthomimetics.com
• UNITED STATES - US FDA Agent
  Emergo Group, Inc., Austin, Texas USA
  Tel: +1.512.327.9997
  Web: www.EmergoGroup.com

Notified Body

OM maintains ISO 13485:2003 certification and is audited every year by:

• KEMA
  Utrechtseweg 310 (Business Park Arnhem) P.O. Box 9035 Arnhem, 6800 ET Netherlands
  Tel: +31 26 3 56 91 11
  Fax: +31 26 4 42 23 33
  Web: www.kema.com