If applicable legislation or regulations require BIOTRONIK to report medical device incidents, this agreement does not prevent BIOTRONIK from doing so. There are many factors to consider, including: parts of this agreement were omitted following a request for confidentiality submitted to CONOR, established and maintains a quality management system in accordance with ISO 13485 and other relevant quality management standards and regulations, such as Council Directive 93/42/EEC of 14 June 1993 on medical devices. CONOR ensures and guarantees that the actual production of the product will take place under the certified quality management system. So you`ve found a great distributor – now what? Medical device manufacturers often underestimate the time and money required to establish and maintain distribution relationships.. . . .