Accelerate Innovation and Ensure Compliance Across Life Sciences
Empower your business with Digital Health Technologies (DHT). We support the compliant adoption of point-of-care devices, wearables, and SaMD in pharma, biotech, and medtech. From regulatory-aligned validation and integration to patient-centric engagement, we help you overcome complexity and deliver impact while you scale innovation responsibly across global markets.
As experts in regulated Life Sciences, including MedTech, BioTech, and BioPharma, we provide specialized services to meet the unique challenges of your industry.
-
Device360 is qointa’s end-to-end solution for regulatory-compliant selection, validation, integration, training, and oversight of Digital Health Technologies in clinical trials.
-
In the highly regulated Life Sciences industry, quality and compliance are paramount. Our expert team provides tailored solutions to help you navigate complex regulatory landscapes, ensuring your products meet the highest standards for safety and efficacy.
-
Appointing qointa as your EU Authorized Representative ensures full regulatory compliance, expert technical file review, and seamless device registration across Europe.
We act as your official liaison with EU authorities, safeguard your interests, and support you through MDR/IVDR obligations—so you can focus on innovation.
-
Ensure the integrity and compliance of your electronic data with our comprehensive services. We specialize in ICT/IT/IS Quality Systems and Audits, Computer Systems Validation, 21 CFR Part 11 & Annex 11 Compliance, and Infrastructure Qualification, delivering robust solutions to safeguard your data.
-
Stay competitive in the evolving digital landscape with our strategic consulting services. We craft and implement tailored digital transformation roadmaps, integrating advanced systems that seamlessly align with your business goals.
-
Transform your product offerings with innovative software solutions tailored for the Life Sciences industry. We specialize in developing Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) solutions that not only meet regulatory requirements but also deliver user-friendly, secure, and cutting-edge technologies.
-
Patient engagement is crucial for improving outcomes and treatment adherence. We provide a range of patient-centric solutions that enhance engagement, optimize healthcare delivery, and gather valuable insights.
-