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Regulatory requirements for clinical evaluations of medical devices increased over the last years, leading to increasingly high effort needed for the creation of required documentation. A significant amount of time is needed to copy & paste information, check consistencies in different documents and eliminate findings identified by Notified Bodies. An important tool to reduce time and labor are software solutions for digital documentation.
This Tech-Talk is aimed at experts working in the medical device industry and responsible for:
- Clinical evaluation processes and/or creation of Clinical Evaluation Files
- Risk management processes and/or creation of Risk Management Files
- Project managers for medical device development projects
- Quality management and regulatory affairs
- IT/digitalization strategy
- Polarion users who want to get inspirations for applications
Digital Clinical Evaluation
This Tech-Talk starts with an overview of expectations of Notified Bodies and common findings. The second part explains, how findings can be prevented and aims to inspire you to see clinical evaluation in a new way: Not as documents with several hundred pages, but as a systematic procedure for identification, appraisal and analysis of different data types - that can be perfectly supported and partly automated with digital solutions.
How notified bodies assess clinical evaluations:
• Requirements of MDCG 2020-13
• General aspects to be considered
• Common findings
How you can prepare yourself:
- Systematic creation of clinical evaluation file content
- Create direct interfaces between processes
- Possibilities provided by digital solutions, e.g. with Polarion
- Create a checklist according to MDCG 2020-13
- What are the expectations of Notified Bodies for clinical evaluations?
- What are common findings that medical device manufacturers receive?
- How can I prepare myself/my company in order to reduce findings?
- How can a digital Polarion Solution support the clinical evaluation process?
Benefits for participants:
- Get an overview of common findings that you should keep in mind for your next clinical evaluation
- Learn how to systematically look at the content of clinical evaluation and efficiently reuse existing information
- Get an overview of the interfaces between development, risk management and clinical evaluation and required data transfer
- Understand the potential of digital solutions for the technical documentation