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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 (QMS) to support its activities. This QMS 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.

  • ISO 13485
  • MDSAP US / Canada
  • IEC 62304
  • ISO 14971
  • IEC 62366
  • 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

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 processess.

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 15 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.

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