Blogs
Here we provide you with key information related to the Medical Device and In Vitro Diagnostic (IVD) industry through Patient Guard’s blogs. We provide invaluable content that delves into the regulation and Quality Assurance of Medical Device and IVDs, with focus on navigating the regulatory landscapes of the United Kingdom (UK), the European Union (EU), and the United States (US).
At Patient Guard, we are not just a source of information; we are your ultimate partner in understanding and maneuvering through the complexities of Medical Device and IVD regulatory requirements, as well as Quality Assurance. Our blogs serve as a beacon, illuminating the latest updates and insights crucial for professionals and organizations operating in these highly regulated sectors.
Patient Guard is not just a repository of information; we are your ally in navigating the ever-evolving landscape of Medical Device and IVD regulations. Join us on this educational journey, where compliance meets excellence.
Categories
While both standards share the same DNA, they serve very different purposes. ISO 9001 is the universal language of quality management; ISO 13485 is its medical-device-specific dialect - one that speaks directly to regulators, auditors, and patients.
As the European MDR and the US FDA’s new Quality Management System Regulation (QMSR) converge, scrutiny has intensified. Every audit now tests whether a company’s medical-device quality management system (QMS) truly works or merely exists on paper.
...
In today’s medical-device sector, ISO 13485 compliance is no longer optional - it’s the ticket to market access, regulatory trust, and operational maturity.
As the European MDR and the US FDA’s new Quality Management System Regulation (QMSR) converge, scrutiny has intensified. Every audit now tests whether a company’s medical-device quality management system (QMS) truly works or merely exists on paper.
...
The alphabet soup of medical device regulation - UDI, EUDAMED, MDR - can make even the most seasoned regulatory manager twitch. But there’s no escaping it: UDI and EUDAMED are now at the heart of European medical device traceability.
...
With ISO 13485 audits tightening worldwide, unprepared medical-device companies face major risks in 2025 and beyond. The regulatory climate has changed fast: global authorities are aligning standards, increasing unannounced inspections, and raising expectations of documentation quality....
The EU MDR supply chain agreement revolution has caught many medical device companies off guard. What started as a regulatory update has evolved into a comprehensive overhaul of how suppliers, distributors, and manufacturers must collaborate. If your contracts still look like they were written during the Medical Devices Directive era, you're playing regulatory Russian roulette....
When it comes to selling medical devices in Europe, most people assume that CE marking is the manufacturer’s responsibility alone. While it’s true that the manufacturer plays the lead role, distributors are not off the hook.
...
