Clinical evaluation- terms & process
Relationship of clinical data, clinical evaluation and clinical evidence and the process of clinical evaluation
Relationship of clinical data, clinical evaluation and clinical evidence and the process of clinical evaluation
Understand the level of support provided at each post-market phase of medical device ……
Get an overview of the new regulatory requirements and liabilities for reprocessing medical devices
In-house devices can be used in health institution without having to comply with most of regulatory provisions of EU MDR or EU IVDR…….
Extend transition period for medical devices and delete “sell-off” deadline from the current EU MDR and IVDR
Dealing with non-compliance situation due to the expired MDD/AIMDD certificate prior to issuance of MDR certificate by applying Article 97 MDR
What are in-house IVDs? What are the new requirements and timelines under EU IVDR and Swiss IvDO for in-house IVDs?
Categorize the clinical trial according to Swiss ClinO-MD must be the very first step towards the planning of clinical trial in Switzerland
How manufacturers and importer can safely and smoothly navigate through the IVDR transitional period for IVDD-certified devices......
Sponsors planning to conduct clinical trials for medical devices in Switzerland or multi-centre clinical trials including Swiss investigational sites should be aware of the changes .....