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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:

Pre-submissions meetings:

Thanks to a significant experience in pre-submissions meetings in diverse therapeutic areas, we have succeeded in building a relationship of trust with the competent authorities who are already aware of our manufacturing and operational processes.

Submissions and approvals:

We have in-house expertise to secure regulatory approvals in different jurisdictions (notably in the U.S, E.U and Canada). In total, we have obtained more than 14 regulatory approvals and go-to-market authorizations for digital therapeutics and connected devices based on our Quality Management System.

Legal manufacturing:

We have the required capabilities to endorse the role of legal manufacturer – our infrastructure and expertise has been tested through years of operations of digital solutions in major global markets.

Contact Us

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.

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