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Regulatory Affairs

Regulatory Affairs

DEVELOPING MEDICAL PRODUCTS CORRECTLY

The global medical product market is strictly ruled. Therefore, it is very important to examine essential regulations in advance. With regard to new regulations for medical devices and In-Vitro-Diagnostics, the European legal framework embodies an essential challenge during the entire product lifecycle.

The AIT intensively examines necessary regulations during their research and innovation activities in the sector of medical devices. Our team is part of significant standard committees and also teaches important subjects at universities. We also focus on defining purpose, assessing conformity, managing risks as well as fulfilling usability requirements and assessing clinical issues.

// Regulatory Affairs (MDD/MDR and IVDR) and ISO 13485 Consulting

Based on our 15-year-long experience as an applied R&D-Organization, developing innovative concepts and products for medical technologies with a certified QM-System according to ISO 13485, we offer specific advice for innovative companies Start-ups when developing new medical devices and In-Vitro-Diagnostics (hard- and/or software) according to MDD/MDR and IVDR. We support our costumers during the initial analysis and development of the regulatory Roadmap, the norm analysis und -realization, the development of an adequate Quality Management System as well as the clinical assessment. We also offer support through the entire European approval process of your medical device.

// Research Services

  • Consulting and Mentoring for medical product innovations and questions to Regulatory Affairs according to MDD/MDR and IVDR, as well as quality management according to ISO13485
  • Development of regulatory Roadmaps for medical products/concepts
  • Operative collaboration when developing RA- and QM-documents
  • Usability, risk management, clinical assessment
  • Supporting the implementation of QM-Systems
  • Supporting the regulatory process