Distributor Agreement Medical Device

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.. . . .

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