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 aspects regarding chemical safety of medical devices. Focus will be on regulatory requirements and chemical testing. In addition, the course will focus on the toxicological evaluation of chemical substances and basic toxicological principles and terms will be explained. Further, the course will cover how to evaluate which type of exposure and which type of effects are of concern, how to gather relevant data and perform a safety assessment and how to estimate risk/ safety of the device.
The course will by use of illustrative examples give you an understanding of:
- Regulatory requirements (MDR) and ISO standards (ISO 10993-1:2018; ISO 10993-17:2009; ISO 10993-18:2020) regarding chemical safety?
- Other regulatory areas to consider REACH, SVHC, RoHS etc.
- Which parts of the device and which type of chemicals to be concerned about
- Which type of data should be gathered
- How to gain the relevant chemical information for the various parts of the device
- How to make a strategy for chemical testing
- How to perform chemical testing
- How and why may chemicals in the device cause hazards
- How to make safety assessment of chemicals in your device
- Where to find relevant data for the safety assessment
Cases will be presented and used for discussions during the course.
Who should attend
The course is relevant for medical device companies and for employees who would like to be introduced to aspects regarding chemical compliance of medical devices - i.e. people who has 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 new-commers in the field of chemical compliance who would like a quick overview of the topic and get a good start for working within the area of chemical safety.
Poul Bo Larsen, Chief Toxicologist, DHI
Brian Svend Nielsen, Principal Toxicologist, DHI
Helle Stendahl Andersen, Business Manager, Teknologisk Institut
"Thorough intoduction to chemicals and search in various databases"
"Skilled supervisors, in depth explanations"
"Detail overview and examples"
Participants, Fall 2021