MedTech company Deep Breath Intelligence (DBI) has partnered with HTEC Group and Effectum Medical to expedite meeting software and documentation requirements for In Vitro Diagnostic Directive (IVDD) compliance of its DBI-EPIbreath software.

DBI-EPIbreath is said to be an easy-to-apply breath test that can offer reliable estimates of circulating concentrations of the antiseizure medication valproic acid to help in patient management.

The software is claimed as the first non-invasive test, CE-marked under IVDD. It enables real-time measurement of valproic acid’s total and free concentrations in a breath sample, with results within 10 minutes.

According to Deep Breath Intelligence CEO Christian Zwicky, the partnership is a major milestone as the startup has invested heavily in researching and developing the medical software.

Zwicky said: “This initiative is a critical step in our mission to broaden the range of medical application for early disease testing in the years to come.

“We really enjoyed the close and professional collaboration with Effectum Medical and the HTEC team which allowed us to identify early critical topics for CE mark, accomplish this project on time and within the targeted budget.”

Under the partnership, HTEC and Effectum Medical will help Deep Breath Intelligence to accelerate the product launch and meet the strict regulatory requirements for IVDD compliance of the DBI-EPIbreath.

Effectum Medical, the official legal maker of the medical device, is said to have brought a team of professionals with regulatory and compliance expertise to help HTEC satisfy the regulatory requirements for breath test software development.

The team also helped Deep Breath Intelligence to achieve product launch in around six months, which would normally take 12 to 18 months by any other standard.

HTEC Group HealthTech head Sava Marinkovich said: “Every medical venture or initiative would like a speedy launch, but only the right skill set and partnership with a client can deliver.

“HTEC’s deep understanding the MedTech space and unique approach to determining a direct-line path to getting a market-oriented medical product certified was mission-critical in the process of accelerating the launch of this revolutionary medical device.”