Unlock innovation and compliance with our tailored end-to-end medical device software development, cutting-edge digital transformation, FDA/MDR compliant software validation, and patient-centric solutions for better healthcare outcomes.

As regulated Life Sciences domain experts (including MedTech, BioTech, BioPharma), we offer: (not inclusive)

  • In the digital age, software is transforming the landscape of medical devices and healthcare solutions. Our experts specialize in developing Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) that not only meet regulatory requirements but also deliver innovative, user-friendly, and safe solutions. Read more

  • Stay ahead in the digital healthcare revolution with our strategic consulting services. We'll tailor a roadmap for your digital transformation journey, implement state-of-the-art systems, and ensure seamless integration. Read more

  • qointa has specialized in providing a broad range of solutions and services relevant to Electronic Data Integrity and Computerized Systems Compliance, including, but not limited to, the following:

    • ICT/IT/IS Quality System and Audits

    • Computer Systems Validation

    • 21 CFR Part 11 Compliance

    • Infrastructure Qualification

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  • At the heart of MedTech industries, adherence to quality standards and regulatory compliance is non-negotiable. Our specialized services in this domain are designed to ensure your products meet the highest standards and navigate complex regulatory landscapes with ease. Read more

  • Engaging patients is essential in today's healthcare landscape. We offer a suite of patient-centric solutions to improve patient outcomes, enhance treatment adherence, and gather valuable insights. Read more

  • From concept to commercialization, we provide a wide array of services for medical device companies, ensuring you stay focused on innovation while we take care of the research and development intricacies. Read more

  • qointa brings a blend of structured systems expertise and innovative market-driven solutions. By engaging with qointa, you gain access to our advisory group and leaders who will play a pivotal role in steering the creation of a successful project.

    Business Strategy
    qointa aids companies by formulating targeted project designs, specific timelines, and project plans tailored to project requirements. We leverage external resources essential for sponsors to achieve project success.

    Project Implementation
    qointa furnishes accomplished project implementation and management teams specialized in healthcare systems. Our proficiencies span database utilization, HIPAA compliance, resource structuring, streamlined operational processes, and the execution of diverse healthcare lifecycle systems such as EDC, LIMS, CDMS, and more ( refer to Cloud Based Clinical Trial Strategy and Development)

  • Whether you require support, a fresh perspective, or simply an additional viewpoint, qointa offers detailed and actionable plans. Feel free to inquire for further information, and we could potentially provide valuable assistance.

Late with your MDR registration? Do you require a Person Responsible for Regulatory Compliance? Talk to us we can help you.