We are regulatory consultants who provide expert medical device and IVD regulatory guidance to help launch products and access new markets.

Services include quality management system and medical device regulatory advice in order to access different markets including:

  • Australian (TGA),
  • EU (CE Marking),
  • United States (FDA),
  • Canada (Health Canada)


Our Clients

We pride ourselves on providing excellent customer service.

Care Essentials
PainChek
CT Healthcare
Care Essentials
Opto
Elastagen
Brauer Natural Medicine
Australian Dental Manufacturing
Signostics