Under the name of DOTimplantSOURCE we are providing integrated outsourcing solutions for Original Equipment Manufacturers and distributors of medical implants and associated instruments... Read more
Under the name of DOTbiomaterials we are manufacturing products of regenerative medicine ... Read more
As a medical technology company we know that quality is of greatest importance for our customers. Deficient products in the health care sector may lead to considerable consequences for manufacturers and patients.
Therefore we have incorporated a modern quality management system which is continuously improved in cooperation with our customers in order to meet highest demands of product safety.
DOT is certified under the international quality management standards for the manufacture of medical devices DIN EN ISO 13485: 2003 / AC: 2009. Our quality and safety standards are also compliant with the demands of Good Manufacturing Practice (GMP).
ISO 13485: 2003 AC: 2009 (DOT-Coatings) [pdf, 0,3MB]
BONITmatrix® EC-Certificate [pdf, 0,3MB]
BONITmatrix® EC-Design Examination Certificate [pdf, 0,4MB]
OSSA NOVA EC- Design Examination Certificate [pdf, 0,9MB]