Nanomaterials are material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale, this webinar will introduce the current situation regarding regulation of nanomaterials within medical devices.
Global regulators are focusing on this area and new legislation will impact your business if you utilize nanomaterials in your products. Join the webinar to hear from Matthew about the current situation regarding, standards, FDA, SCENIHR, EU directives and how the new medical device and IVD Regulations will impact this technology area.
If you are using nanomaterials in any part of your product the presentation will provide you with critical information regarding global market assess including classifications of the products and potential impacts on your business in the future.
This free BSI webinar will cover:
- Nanotechnology and nanomaterials
- Medical devices that contain nanomaterials
- Relevant standards
- ISO 10993-22 (draft standard under development)
- Nanomaterials and the new EU medical devices regulations
- Current EU position
- SCENIHR report
- UK and MHRA
- FDA position.
Matthew O'Donnell is a product technical specialist in the BSI Orthopedic and Dental team. Matt works as a scheme manager, liaising with clients to manage their certification process and conducting conformity assessments. He is also a lead QMS assessor, auditing clients against the requirements of ISO 13485.