Quality Management Systems
Our Quality Management System (QMS) Services for Medical Devices are designed to ensure that your products are safe, effective, and fully compliant with local and international regulatory standards. We provide comprehensive support that covers every stage from market launch to post-marketing surveillance.
DISCOVER MOREQMS for Medical Devices: Safety, Compliance & Standards
A Quality Management System (QMS) constitutes a set of designed and structured processes, policies, and procedures that help ensure that medical devices are safe, effective, and compliant with international regulatory standards. This medical device quality management system is pivotal in ensuring that each product meets the quality and safety benchmarks established by regulatory bodies. The QMS must adhere to regulations and standards such as ISO 13485:2016, the US FDA Quality System Regulation (QSR), and the European Union Medical Device Regulation (EU MDR).
These regional regulations provide clear guidance for establishing, implementing, and maintaining QMS processes. Medical device manufacturers are required to follow target country-specific standards for product distribution. By aligning with these standards, our services help ensure that every medical device meets strict safety and reliability criteria, paving the way for successful market entry.
Lifecycle Integration & Stakeholder Engagement
QMS is an essential element throughout the lifecycle of a medical device – from initial design and development, through manufacturing and distribution, to post-marketing surveillance (PMS). This comprehensive system involves various stakeholders, including manufacturers, regulators, healthcare providers, and patients, ensuring that every phase of a device’s lifecycle is managed with precision.
DDReg offers QMS services across a broad spectrum of products including medical devices, in vitro diagnostic (IVD) devices, combination products, and software as medical devices (SaMDs). Our services are tailored to meet specific regulatory demands and support sustainable compliance.
Our Quality Management System Expertise
- QMS Implementation: Support with ISO 13485, MDSAP, 21 CFR820, BGMP, Indian MDR, etc.
- SOP & Quality Policy Development: Creation of SOPs, templates, quality policies, and Risk Management files.
- QMS Auditing: Internal Audit and Pre-Certification Audit services.
Ready to enhance your QMS for medical devices and ensure regulatory compliance?