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
On-Demand Webinar: Computer Software Assurance for Medical Device QMS Processes
When a process is digitized with the help of a software, validation of the software is mandatory. This is required by ISO 13485 and also by the FDA in 21 CFR Part 820. However, there are significant differences in the concrete approach and the required effort.Therefore, it is crucial to have an appropriate software validation process established that allows flexibility for the different use scenarios.
On-Demand Webinar: Benefit Risk Determination for Medical Devices
A huge problem in the MedTech industry: The 𝗶𝗻𝘁𝗲𝗿𝗳𝗮𝗰𝗲 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 & 𝗿𝗶𝘀𝗸 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗳𝗶𝗹𝗲, and in particular the 𝗯𝗲𝗻𝗲𝗳𝗶𝘁-𝗿𝗶𝘀𝗸 𝗱𝗲𝘁𝗲𝗿𝗺𝗶𝗻𝗮𝘁𝗶𝗼𝗻 section in the clinical evaluation report. We strive to bring more clarity into that topic and help you understand current struggles of medical device manufacturers and how you can handle those.