Regulatory Compliance Support

Hydrix has extensive experience in designing to, and supporting our Clients in gaining certification to a wide variety of other local and international standards across biomedical, industrial, wireless and other regulated domains.

Hydrix has proven experience in the creation of detailed Design History Files that meet the requirements of Australian TGA, US FDA and European CE guidelines for prescribed medical devices up to Class 3 High Risk. Working with our wide network of medical regulatory specialists, all with a track record of success in gaining approval in most major markets means that the compliance process is swift and painless.

Hydrix is also well versed in the creation of design information packs and submission to suit local and international electrical, emissions, lead-free (RoHS), recyclability (WEEE) and other regulatory requirements.