The requirements of the MDR pose new challenges for manufacturers of software that is to be marketed as a medical device. We have prepared information for you that will show you possible courses of action.

DQS Medizinprodukte GmbH has prepared information on the handling of medical software based on the requirements of the (EU) 2017/745 Medical Devices Regulation (MDR). This information addresses the delimitation of software, classification rules, conformity assessment procedures, quality management system requirements and much more.

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Learn more about software as a medical device under MDR

* Delimitation of Software
* Classification of Software
* Conformity Assessment Procedures
* QMS Requirements
* Responsible Person
* Technical Documentation

Michael Bothe

Michael Bothe is Head of the Notified Body for Active Medical Devices and is also a lead auditor. He is also involved in standardization at the German Institute for Standardization (DIN) and the German Commission for Electrotechnical, Electronic & Information Technologies (DKE) and coordinates continuing education activities for customers. His interests include integrated audits as well as process optimization of conformity assessment procedures.