Medical Device Quality Management System
Empower your patients with a companion app to improve their treatment experience.
Companion apps are designed to support patient onboarding, engagement and adherence around a specific treatment. These digital solutions are highly user-centric, offering personalized support and resources to help patients better navigate their treatment journey.
Common key features includeÂ
Physical activity and nutrition programs additional modules tailored to each specific use cas
Patient safety and data protection are core to our development approach. We combine UX design, medical, engineering and quality expertise to deliver solutions that meets high standards of reliability, security and compliance.
Our teams operate within regulated quality systems and secure hosting environments to support the responsible deployment of digital health solutions.
A disease management platform provides a proactive and comprehensive approach that aims to improve the quality of life of patients with chronic diseases, while seeking to reduce healthcare costs.
It involves coordinated interventions and communications between different stakeholders for chronic diseases where self-management efforts can play an important role. By leveraging a comprehensive digital platform, patients can easily track the progress of their disease, communicate better with their healthcare team and live an enhanced treatment experience.
SaMD offers pharmaceutical companies an opportunity toextend the value of their therapies through regulated digital asset. . By developing a SaMD solution, we help patients managing their medication more effectively and enhancingthe treatment adherence. Building and validating clinical evidence through rigorous trials and studies ensures the safety and efficacy of these solutions.
When integratedwith drug assets, SaMD contributes to a more personalized and comprehensive treatment experience, ultimately improving outcomes and patient satisfaction.
Our technology platform integrates with established solutions/PSPs to optimize patient experience through complementary digital modules. By leveraging pre-developed modules, our PSP solutions help reduce development timelines while addressing patients’ evolving needs, including engagement, education, and adherence support.
SureStartRx® is a tailored digital program designed to support patients initiating self-injected therapies. Developed with our sister company Noble, an Aptar Pharma company, the program combines a training device with digital education from the first dose.
SureStartRx® helps bridge the gap between dispensing medication and long-term adherence by supporting patients early in their treatment journey.
Patient safety is a fundamental element in our development process.
By combining our design, clinical, engineering and quality assurance capabilities.
ISO 13485
MDSAP US / Canada
IEC 62304
ISO 14971
IEC 62366
ISTQB
HIPAA
GDPR
Medical Device Quality Management System
Certification for secure hosting and protection of sensitive health data in compliance with French regulations
Information security management standard
Regulatory audit for the requirements of the regulatory authorities in the U.S, Canada, Japan, Brazil and Australia
Software Development Lifecycle Management
Risk Management for Medical Device
Usability & Human Factors Engineering of Medical Device
International Software Testing Qualifications Board
Health Insurance Portability and Accountability Act compliant
General Data Protection Regulation compliant in the European Union
MigraineBuddy is the #1 headache and migraine tracking app. It is engineered to enhance the quality of life for those living with migraines by facilitating meticulous tracking, reporting, and self-management of symptoms, which in turn can accelerate diagnosis and fine-tune treatment options.
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Oleena® is a prescription mobile app designed to empower cancer patients to self-manage their symptoms using evidence-based algorithms. By providing personalized recommendations and continuous monitoring, Oleena® enhances patients’ quality of life and treatment adherence. The app also facilitates remote monitoring by care teams, ensuring timely interventions and improved clinical outcomes.
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Physio.me is a comprehensive mobile app designed for individuals with neuromuscular conditions (NMD). It allows users to track their training progress with their physiotherapists, stay motivated with tutorial videos and a rewards system. Only physiotherapists can create personalized exercise programs through a dedicated online platform, where they can also manage and monitor each patient’s progress effectively.
Find out moreBuild companion apps that integrate seamlessly with Patient Support Programs using Aptar Digital Health’s platform, which offers a suite of customizable modules. Our platform is designed to enhance patient engagement and streamline healthcare management.
Tailor the app to meet specific needs with a variety of modules, including medication reminders, symptom tracking, and educational content.
Sync patient data in real-time to provide healthcare providers with up-to-date information, enabling timely interventions and personalized care.
Ensure ease of use for patients of all ages with an intuitive and accessible design.
Maintain the highest standards of data security and compliance with healthcare regulations, ensuring patient information is protected.
Gain insights into patient behavior and program effectiveness with comprehensive analytics and reporting tools.
Give patients greater control over their disease with tools that enable them to track their progress, set goals, manage their treatment plans, and reduce anxiety
