BAYOOSOFT @DMEA 2021

Digital tools can support manufacturers to centrally map the clinical evaluation according to the Medical Devices Regulation MDR 2017/745, MDCG & MEDDEV 2.7/1 rev 4, to standardise procedures and to document them comprehensibly. This makes quality management faster and more efficient, while redundancies are avoided and symbioses are used.

The practical lecture gives an overview of how a clinical evaluation can be completely covered and accelerated with tool support.

Operators of medical IT networks cannot avoid dealing with the IEC 80001-1 standard. A systematic risk analysis should ensure the safety of patients and staff, data and system security as well as effectiveness.

Therefore, the standard requires risk management throughout the life cycle and the preparation of a risk management file. The lecture will show you how to comply with the requirements without losing the overview.

The EU Medical Devices Regulation places enormous regulatory demands on manufacturers. Technical documentation in particular is subject to detailed specifications and a constant obligation to keep it up to date. Focus on the essentials, the content.

BAYOOSOFT Risk Manager supports you in the standard-compliant creation of technical documentation for medical devices and in-vitro diagnostics. The leading software solution helps you to accelerate the path to approval.