THE EU REGULATORY LANDSCAPE IS CHANGING
IS YOUR DEVICE GOVERNED BY THE MDD?
Are you aware of the MDR changes?
Regulatory scrutiny has increased significantly
Is your Technical File/Design dossier compliant?
How will you attain the higher levels of compliance?
ARE YOU PREPARED FOR THE IVD RECAST?
Do you understand how the IVDR will be implemented?
What new classification does your device fall under?
Do you self-declare all or some of your devices?
How many of your IVDs will require full certification?
ISO13485:2016 HAS NOW BEEN RELEASED
If you are already certified, are you aware of the changes?
How does it affect your current QMS?
WILL BREXIT AFFECT YOUR EU BUSINESS?
Will you look to other regions of the World to sell?
USA/Canada, India, China, Brazil?