Engage
Discuss your SaMD program
A first conversation is senior, short and direct. If the mandate is not one we should hold, you will be told so — and told why.
Direct
Core markets
United States
FDA
European Union
EU MDR
United Kingdom
MHRA
Canada
Health Canada
Australia
TGA
Switzerland
Swissmedic
Extended: Japan · China · Brazil · Selected Asia-Pacific
Useful to include
- Device class, intended use and target markets
- Where the program stands against its committed dates
- What is currently preventing progress
- Whether a quality system is already established
Enquiries reach the Principal directly. Details you provide are used solely to respond — see the privacy notice.