About the event
This one day event brings together experts from both Element and Chorley Consulting to give medical device manufacturers the opportunity to learn more about the expectations for E&L studies from regulators, how those studies are performed and how the data is evaluated. All under the same roof, on the same day!
The event will provide participants the opportunity to speak directly with a range of experts in both analytical chemistry and toxicological assessment to help you understand what may be required for your device and how it can help you to demonstrate the biological safety of your device.
During the day there will be presentations from experts at Chorley Consulting and Element Materials Technology on:
- What do the regulations say?
- What is the process for establishing biological safety?
- How to prepare extracts from your device
- What analytical chemistry can tell us
- What can a toxicologist do with the information?
Full event agenda
- 09:30 – 10:00: Welcome and Coffee
- 10:00 – 10:15: Intro to Element Life Sciences and H&S aspects
- 10:15 – 10:30: Intro to Chorley Consulting and The importance of collaboration between the Chemistry lab and Toxicologist
- 10:30 – 11:00: When and Why Chemical Analysis May be Needed. What MDR and ISO 10993 tell us.
- 11:00 – 11:30: Introduction to Chemical Characterisation of Medical Devices (ISO 10993-18)
- 11:30 – 12:00: Lab Tour 1/Q&As
- 12:00 – 12:45: Lunch
- 12:45 – 13:15: Guest Speaker - Lessons Learnt During Biocompatibility
- 13:15 – 13:45: Introduction to the Analytical Methodologies used to Support the Biocompatibility Evaluation of Breathing Gas Pathway Devices (ISO 18562)
- 13:45 – 14:15: Toxicological Risk Assessment; What Toxicologists do with Your Data.
- 14:15 – 14:45: Lab Tour 2/Q&As
- 14:45 – 15:00: Coffee
- 15:00 – 16:00: Panel Discussion
- 16:00: Close
Take a laboratory tour
You will also have the opportunity to have a tour of the laboratory facilities and discuss technical aspects of E&L studies with the experts. If you have any questions specific to your device, then there will be an opportunity to book a confidential consultation with an appropriate expert from Chorley Consulting and/or Element Materials Technology.
Meet the experts
The event will be held at our Manchester Life Sciences Lab,
Element’s Materials Technology: Waterside Court, 1 Crewe Road, Wythenshawe, Manchester, M23 9BE. Link to Google Maps
There is free parking on site.
Welcome to Element Manchester
Our Manchester laboratory is home to over 50 life science experts dedicated to helping our clients ensure patient safety.
We bring cutting-edge extractable & leachable techniques, state-of-the-art equipment, and knowledge of regulatory standards to provide high quality analytical data to help you make key decisions on your product.
Find out more
Find out about our testing capabilities for the Antimicrobial, Food, Medical Devices, Pharmaceutical, Biotechnology, and Personal Care industries.
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
Element’s pharmaceutical laboratories provide specialist pharmaceutical testing services, including chemical, physical, microbial, and stability testing on a vast array of products, from raw materials to finished products.
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.