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Quality & Regulatory

Focused on patient safety and driven by excellence, we put quality at the heart of everything we build.

Driven by excellence and safety

Our Quality Assurance department ensures compliance with regulations and standards, trains employees to our quality processes and manages regulatory approvals and registrations. All our methods are driven by excellence and safety.

Aptar Digital Health leverages an ISO 13485 and MDSAP (USA & Canada) certified quality management system to support its activities. This quality management system has been tailored to develop medical devices and Software-as-Medical-Devices and complies with global regulatory requirements and standards, with a particular emphasis on US and EU regulations (FDA 21 CFR part 820, EU 93/42/EEC and MDR 2017:745). Since 2010, 15 regulatory approvals and go-to-market authorizations for digital therapeutics and connected devices were obtained based on our Quality Management System and technology platforms.

Patient safety is a fundamental element in our development process. By combining our design, clinical, engineering and quality assurance capabilities, our risk management team can implement robust processes to monitor and manage product risks during design, development, and operation. In addition, we apply the ISO:14971 standard for medical device risk management.

Our Regulatory Affairs team collaborates with our partners to define the best regulatory pathway for each digital solution we co-develop. We especially offer support in:

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Aptar Digital Health is dedicated to improving patient experiences as your global partner. Contact us to explore how our robust digital solutions can help you accelerate your healthcare initiatives with confidence.