A board member at Spectre Technology, a digital health manufacturing company helping chronic disease patients improve their quality of life by specializing in developing software as a medical device (SaMD) and digital therapeutics (DTx) products. Spectre Technology company is registered as a manufacturer in the EUDAMED database under the registration number Actor ID/SRN HR-MF-000044251, approved by the Halmed Agency for Medicinal Products and Medical Devices/Competent Authority based in Croatia. Authorized person: Antonela Šimunović-Head of Department, Medical Devices, Email: antonela.simunovic@halmed.hr. Besides medical technology, we have a specialized department that handles medical affairs, regulatory affairs, validation, and registration of medical devices, and IVDs under the EU MDR 745/2019 regulation within the European Union. Regulatory compliance services include EU MDR, CE Marking, and ISO 13485:2016 consulting for medical device and in-vitro diagnostics companies within the European Union. We work with life science industry partners to develop evidence-based digital health products under medical device regulatory and quality management standards. Using our ISO 13485:2016 certification, we can develop, operate, launch, and maintain SaMD and DTx software solutions under the highest medical industry standards. Located in central Europe-Zagreb, Croatia, we can act as a critical supplier/subcontractor to develop digital health solutions in close collaboration with life sciences, medical devices, and biotechnology industries.