Are you developing a in vitro diagnostic device for the health sector? Are you unsure if you need to adhere to the In Vitro Diagnostic Medical Device Regulations? Or what the risk classification of your device is according to the In Vitro Diagnostic Medical Device Regulations? Or which requirements your device need to conform to? Then this workshop is for you.
Join our online workshop to discover how to navigate the complex landscape of medical device regulation.
The objective of this workshop is to learn the first key aspects of the In Vitro Diagnostic medical device regulations: to determine when a product is a in vitro medical device, what the risk classification of the device is and what the next steps are.
Who is this for?
People who are working in the area of In vitro diagnostic medical devices, including: academic researchers, clinicians, science students, innovators, start up’s, SME’s, research council, research services and tech transfer support.
What will you gain?
By the end of the workshop, you will be able to:
- Identify if a device is an In vitro diagnostic medical device.
- Classify a device according to the In Vitro Diagnostic Medical Device Regulation (EU) risk levels.
- Find the requirements that In Vitro Diagnostic medical devices need to conform to.
- Hands on experience in using the regulatory tool: RegMetrics.
Reserve your place on Eventbrite: https://ivdr2026.eventbrite.com
Workshop Lead: Rita Hendricusdottir, CEO of RegMetrics
Rita Hendricusdottir is the CEO of RegMetrics and holds a PhD in Neuroscience at King’s College London. She is passionate about making sure that patients have access to the latest technologies that can
improve their life. In order for MedTech companies to bring new medical devices to the market, they have to adhere to the medical device regulations. The challenge is to bridge the knowledge gap between
engineering and law. Rita has always been fascinated in how to best connect disciplines in order to generate the strongest outcomes. Her previous work experience has been on bridging the gap between
biology and bioinformatics to ensure better collaboration (ELIXIR) or to ensure that Pharma departments had the same understanding of a subject area (OxfordPharmaGenesis).
About RegMetrics
RegMetrics (www.reg-metrics.com) is a regulatory compliance software that supports you with the regulatory requirements step by step. The software is easy to use, saves time and no prior
regulatory knowledge is required. RegMetrics provides an objective and trustworthy approach with all its content referencing official documents, whilst using data driven technologies to cater to all types of medical devices from software to hardware, as well as in-vitro diagnostics.
For more information contact us on rita.hendricusdottir@reg-metrics.com