Quality & regulatory

Responsibility, documentation and continuous improvement in medical technology development.

Our commitment

Committed to quality

BirthTech’s policy guides medical device manufacturing and supply, compliance with applicable requirements and continuous process improvement.

Commitment to product safety, effectiveness and performance.

Improving processes and the quality management system.

Considering regulatory and legal requirements relevant to devices and markets.

Organizing information to support use and document traceability.

Team training and commitment to the organization’s quality objectives.

Access documents made available by BirthTech. Consult each document for its content, scope and date.

URS certificate for the quality management system of Birthtech – Dispositivos Para Saude, Lda. See the document for its scope and validity.

View the document made available by BirthTech.

Access the European registration document published by the company.

PreemieTest — version 05, available in BirthTech’s document archive.

The PreemieTest user manual in English.

The apps are part of the BirthTech digital ecosystem, providing resources to support healthcare professionals and the use of PreemieTest.

Android · iOS

An application for neonatal risk assessment and support for healthcare professionals, based on BirthTech clinical algorithms.

Android · iOS

A companion application for PreemieTest to connect the device, view data and update the equipment.

Need additional documentation or clarification on a technology in a particular market? Our team can assist with your inquiry.

Talk to our team about products, research and opportunities to collaborate.