Medical Device Quality Management System
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
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
We especially offer support in:
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.
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.
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.