Join this workshop hosted by DHI and the Danish Technological Institute (TI) and learn what you need to know about chemical characterization and safety assessment of medical devices.
The new Medical Device Regulation (MDR) subjects the medical device industry to increased requirements for justification in terms of chemical characterization and safety assessment of their devices.
At this workshop DHI and TI, two experienced partners in the field of testing and assessment of medical devices, will guide you through the regulatory requirements of chemical characterization and safety assessment.
Based on experience and how-to-do, we will present a step-by-step approach to a strategy for testing and documenting your device.
During the workshop we will discuss how to overcome obstacles that may occur during the process.
You are invited to contribute with questions or examples and to share your experience.
09:30 – 09:35 Welcome (DHI and TI)
09:35 – 09:50 Overall concept of chemical safety assessment of medical devices (DHI)
09:50 – 10:35 Chemical characterization and how to perform extraction testing and chemical analysis (TI)
10:35 – 10:45 Questions and discussions (TI)
10:45 – 10:55 Break
10:55 – 11:40 Toxicological safety assessment (DHI)
– principles behind the safety assessment
– step-by-step approach to safety assessment of the analytical chemical data
11:40 – 12:00 Questions, discussions and wrap-up of workshop (DHI and TI)
DHI A/S
Danish Technological Institute (TI)
The workshop is aimed at professionals from small- and medium-sized companies that market medical devices in the EU or the US market and are challenged by regulatory compliance.
To participate it will be an advantage if you have some general knowledge and experience with the MDD and MDR and the ISO 10993 series on biological evaluation.
18 June 2021 from 9:30 – 12:00 (CET)
Participation fee: DKK 1,500 excl. VAT
Registration deadline: 16 June 2021
Please note that a limited number of seats are available.
Price: € 600 excl. vat.