Medical Device Quality Management System
Empower patients with a digital app to improve their treatment experience.
Companion apps, or digital Patient Support Programs (PSPs), are designed to improve patient onboarding and adherence to a specific treatment. These digital tools are typically non-regulated, non-interventional, and highly user-centric, providing patients with personalized support and resources to help them navigate their treatment journey.
Digital PSPs can be developed as stand-alone solutions or embedded as specific modules into existing digital health products, such as Aptar Digital Health MigraineBuddy.
Key Features
SaMD offers pharmaceutical companies unique opportunities to differentiate their products and deliver greater value. By developing dedicated SaMD solutions, we help patients manage their medication more effectively and enhance treatment adherence. Building and validating clinical evidence through rigorous trials and studies ensures the safety and efficacy of these devices.
Integrating SaMD solutions with drug assets creates a more comprehensive and personalized treatment experience for patients, ultimately improving outcomes and patient satisfaction.
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
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.
Download the AppBuild 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
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