qointa
Qointa is a specialized provider of solutions and services for the regulated Life Sciences industry, including pharma, biotech, and medtech sectors. Their mission is to accelerate innovation, ensure compliance, and deliver impactful healthcare outcomes through digital transformation, regulatory assurance, data integrity, patient engagement, and software development. They focus on quality, regulatory mastery, and tailored solutions to meet the complex needs of their clients, ranging from startups to global industry leaders.
Industries
Nr. of Employees
small (1-50)
Products
Adherence platform for medication and therapy
Web- and mobile-accessible adherence solution that delivers reminders, collects real-time adherence and wellbeing data, and supports patient-brand engagement.
Remote patient monitoring platform
Platform that collects vital signs and patient-reported data (active and passive), packages and delivers data to clinicians and carers, and supports alerting and intervention workflows.
Patient registry and disease management platform
System to create disease-specific medical files and registries that bridge pretrial monitoring, clinical trial eCRFs and post-market real-world evidence collection.
EU Authorized Representative Services
Full-scope EU Authorized Representative services for non-EU medical device manufacturers to ensure regulatory compliance under EU MDR 2017/745 and IVDR 2017/746.
Clinical Trial
Comprehensive service for designing and managing clinical trials adhering to scientific and ethical standards, from protocol development to site selection, patient recruitment, and data collection.
Clinical Trial Support Services
Advisory and support for clinical trial technology solutions, data collection, analysis, and reporting for clinical studies.
Adherence platform for medication and therapy
Web- and mobile-accessible adherence solution that delivers reminders, collects real-time adherence and wellbeing data, and supports patient-brand engagement.
Remote patient monitoring platform
Platform that collects vital signs and patient-reported data (active and passive), packages and delivers data to clinicians and carers, and supports alerting and intervention workflows.
Patient registry and disease management platform
System to create disease-specific medical files and registries that bridge pretrial monitoring, clinical trial eCRFs and post-market real-world evidence collection.
EU Authorized Representative Services
Full-scope EU Authorized Representative services for non-EU medical device manufacturers to ensure regulatory compliance under EU MDR 2017/745 and IVDR 2017/746.
Clinical Trial
Comprehensive service for designing and managing clinical trials adhering to scientific and ethical standards, from protocol development to site selection, patient recruitment, and data collection.
Clinical Trial Support Services
Advisory and support for clinical trial technology solutions, data collection, analysis, and reporting for clinical studies.
Services
Advisory and implementation services for QMS, regulatory strategy, technical file review and submission support for medical device and biotech clients.
Acting as the official EU representative to fulfil MDR/IVDR obligations, manage technical files and liaise with EU authorities.
Validation planning, audits, controls design and infrastructure qualification to meet 21 CFR Part 11 and Annex 11 requirements.
Roadmapping, technology selection and implementation support for digital modernization in manufacturing and clinical operations.
Design, development and validation of SaMD/SiMD including risk management, verification and documentation aligned with IEC 62304 and regulatory requirements.
Design and deployment of patient support programs, adherence reminder systems and disease-specific registries that integrate with clinical workflows.
Advisory and implementation services for QMS, regulatory strategy, technical file review and submission support for medical device and biotech clients.
Acting as the official EU representative to fulfil MDR/IVDR obligations, manage technical files and liaise with EU authorities.
Validation planning, audits, controls design and infrastructure qualification to meet 21 CFR Part 11 and Annex 11 requirements.
Roadmapping, technology selection and implementation support for digital modernization in manufacturing and clinical operations.
Design, development and validation of SaMD/SiMD including risk management, verification and documentation aligned with IEC 62304 and regulatory requirements.
Design and deployment of patient support programs, adherence reminder systems and disease-specific registries that integrate with clinical workflows.
Expertise Areas
- Clinical trial management and eClinical systems
- Regulatory compliance and medical device registration
- Quality Management Systems (QMS) for life sciences
- Software development and validation for regulated products
Key Technologies
- Cloud-based analytics and hosting
- Electronic data capture (eCRF)
- ePRO / eCOA systems
- Remote patient monitoring platforms
News & Updates
How small companies can overcome validation challenges on tight budgets, and the importance of proper documentation.
Strategies to streamline compliance processes, manage risks, and ensure patient safety in medical devices.
Proactive risk management across the product lifecycle, aligning with ISO 14971 and modern regulatory challenges.
Guidance on managing cybersecurity risks in medical devices, ensuring compliance and patient safety.
Understanding validation in the life sciences industry, its importance, and modern practices.
Benefits of engaging external consultants for faster market success and regulatory compliance.
How small companies can overcome validation challenges on tight budgets, and the importance of proper documentation.
Strategies to streamline compliance processes, manage risks, and ensure patient safety in medical devices.
Proactive risk management across the product lifecycle, aligning with ISO 14971 and modern regulatory challenges.
Guidance on managing cybersecurity risks in medical devices, ensuring compliance and patient safety.
Understanding validation in the life sciences industry, its importance, and modern practices.
Benefits of engaging external consultants for faster market success and regulatory compliance.