Introduction to Chemical Compliance for Medical Devices
The objective is to give participants an understanding of their obligations regarding justification of chemical safety of their devices - and how to tackle these obligations
Course objective and outcome
The objective is to give participants an understanding of their obligations regarding justification of chemical safety of their devices - and how to tackle these obligations.
The course will give the overall framework in relation to determining the chemical safety of medical devices. The focus will be on regulatory requirements, chemical testing and chemical safety evaluation using toxicological information obtained from literature searches. The course will provide you with a structured and cost-effective strategy to guide you through the process of obtaining sufficient justification for the chemical safety of your device using illustrative examples. These considerations are relevant for selection of materials in product development, device registration and changes to materials/suppliers.
The course will use illustrative examples to give you an understanding of:
- Regulatory requirements (MDR) and ISO 10993 standards (with focus on ISO 10993-1; ISO 10993-17; ISO 10993-18) regarding chemical safety
- Other regulatory areas to consider: REACH, SVHC, RoHS, etc.
- How to obtain the relevant chemical information for your device
- How to decide when testing is necessary
- How to make a strategy for chemical testing & reduce time to market.
- How to perform chemical testing and understand how to choose among various methods.
- How to assess the safety of chemicals in your device based on toxicological information
- Where to find relevant information for the safety assessment.
Cases will be presented and used for discussions during the course.
Who should attend?
The course is relevant for employees of medical device companies who would like to be introduced to aspects regarding chemical compliance of medical devices - i.e., people who have no in-depth knowledge of the topic but who would like to get a better understanding in order to communicate with specialists in the field. Especially, the course is relevant for newcomers in the field of chemical compliance who would like a quick overview of the topic and a good start for working within the area of chemical safety.
"Thorough introduction to chemicals and search in various databases"
"Skilled supervisors, in depth explanations"
"Detail overview and examples"
Participants, Fall 2021