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Hos DHI finder du et af Europas stærkeste tværfaglige miljøer om kemiske stoffer og deres effekter på mennesker og miljø.
Vi hjælper industrien med at opfylde kravene til sikre produkter og med at overholde kemikalielovgivninger over hele verden.
Vi er en del af DHI Group.
Through three free webinars we describe what you should know about your legal responsibilities for medical device safety. What does it take to comply with the safety requirements in the new EU regulation (MDR) and updates of the ISO standards.
This first webinar gives you an overview and approaches to safety evaluation of medical devices according to requirements in the MDR and ISO 10993-1(2018).
This free webinar is about safety assessment by means of chemical characterization.
We address requirements and recommendations in ISO 10993-18, including selection of tests and analyses to support biological evaluation, requirements for studies of extractable and leachable substances for medical devices and more.
In this free webinar we focus on biocompatibility evaluation of drug delivery devices using ISO 10993-1(2018) for drug-device combination products.
You will get an overview of how to approach safety evaluation of drug delivery devices in accordance with the EU MDR regulation and the updated ISO 10993-1 standard. You will also learn about device categorization and physical and chemical characterization.
Kurset giver dig overblik over kravene til sikkerheden af fødevarekontaktmaterialer i EU for emballage, køkken- og produktionsudstyr.
Du lærer desuden at udforme en overensstemmelseserklæring og at vurdere, om den er tilstrækkelig til dit formål.
A two-day theoretical course in October that introduces you to the fundamentals in toxicology and risk assessment, including the most important databases.
After the course you will have a better understanding of hazard and risk assessments and how to carry out data searches.
