Interfaces between Risk Analysis, Clinical Evaluation and Usability Engineering
In this on-demand webinar we will explain the interfaces and demonstrate, how you can link information between these processes in Polarion in order to demonstrate compliance with regulatory requirements.
On-Demand Webinar: Clinical Evaluation: Perspective of Notified Bodies
Regulatory requirements for clinical evaluations of medical devices increased over the last years. An important tool to reduce time and labor are software solutions for digital documentation.
On-Demand Webinar: Efficient Handling of Regulatory Requirements and Integration into Product Development
Get a quick overview, which regulatory requirements are relevant for which products and easily integrate them into your product development process.
On-Demand Webinar: Software Validation in the Medtech Industry
Software used for the support of processes in quality management systems (QMS) must be validated to confirm that the software fulfills the intended purpose. Important to understand is, that the validation must be conducted on the basis of the application process and in the IT environment of the software operator.
On-Demand Webinar: Medical Device Development
It's no secret: One of the biggest challenges in product development are "silos" of information. They arise from processes that are not interlinked and specialist process teams that are not able to exchange information efficiently