Articles

ISO 13485:2016 outlines the requirements for a quality management system (QMS) where organizations must demonstrate their ability to provide medical devices and related services that consistently meet applicable regulatory and customer expectations. It applies to all stages of the product lifecycle, including design, development, production, storage, distribution, installation, and servicing.

In the highly regulated and safety-sensitive world of medical devices, continuous compliance with international standards is not merely a regulatory checkbox—it is a strategic imperative.

The article studies the dynamics and repercussions of the projected FDA shutdown in 2025, analyzing its impact on essential services' continuity and the ramifications for pharmaceutical and technological innovation.

Simplify your EU MDR compliance with expert EUDAMED support. Sterling Medical Registration provides Full-service support for manufacturers and importers navigating the European Database on Medical Devices (EUDAMED). From account setup to device registration and ongoing maintenance, we ensure your data is accurate, compliant, and audit-ready.

Compliance with EU MDR 2017/745 requires meeting the European Union’s rigorous regulatory framework for medical devices, introduced to strengthen patient safety, product performance, and market transparency by replacing earlier directives.

Sterling Medical Registration offers a full suite of regulatory services tailored to medical device manufacturers seeking FDA clearance and ongoing compliance. From initial submissions to post-market obligations, our team ensures your product meets all necessary standards for safe and lawful distribution in the U.S.

The FDA has officially aligned its Quality System Regulation (QSR) with ISO 13485:2016 to promote global harmonization in medical device regulation.

For medical device companies, ISO 13485 certification is more than a regulatory checkbox, it is a signal of quality and trust to customers and regulators alike.