Stelar Research UG
EU, Turkey, Switzerland, Norway, Serbia, Iceland and Macedonia.
Stelar Security Technology Law Research UG (haftungsbeschränkt) is a start-up established in Hamburg (Germany) that aims to promote education and research through the implementation of scientific courses and research projects and the award of research contracts. We are specialised in research on legal assessment methods for “Privacy by Design” of new security technologies and privacy management systems for manufacturers of ICT products and related service providers.
Stelar was founded as a spin-off of an integrating project with seven main partners funded by the German Federal Ministry of Education and Science (BMBF) within its Framework Programme “Research for Civil Security.
In addition to research and legal aspects of medical devices, we can offer you expertise in the CE certification process of medical device software.
Areas of regulatory/reimbursement support:
In order to use the CE mark and issue the Declaration of Conformity, we are happy to help you find out: – if your software is standalone or not, – if it is subject to the MDR or not, – how to classify it (MDR classification rules),- which one of the processes we need to follow (conformity assessment procedures), – if we need to involve a third party for assessment, audit and/or review (Notified Body), – how to conform to quality management system standards (ISO/IEC 9001, ISO 13485), – what to write in your software documentation to demonstrate compliance with MDR requirements, – how to make your software traceable and follow up on its marketing, – what steps are needed to demonstrate GDPR compliance, – how to help your customers demonstrate compliance with the legal obligation of “data protection by design” (GDPR Article 25) and
what processes you can set up or update to conform to security and privacy management system standards (ISO/IEC 27001, ISO/IEC 27552).